TuberculosisPhase 1NCT05824091
Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults
A Phase 1 study testing MK-7762 (TBD09) in people with Tuberculosis, run by Gates Medical Research Institute at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of single and then multiple doses of MK-7762 (TBD09) in healthy volunteers in the context of a first-in-human study. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- MK-7762 (TBD09)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2023to 26 Mar 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be included in this trial, an individual must satisfy all the following criteria:
- Is ≥ 19 to ≤ 55 years of age.
- Is healthy as determined by the Investigator via medical history and clinical examination before enrollment in the trial.
- Can understand and comply with the trial and site procedures, understand the risks involved in the trial, and provide written informed consent before the first trial-specific procedure.
- Can complete all Screening period evaluations and stay in the clinical research facility for the duration of the inpatient periods of the trial.
- Has BMI between 18 and 32 kg/m2, inclusive, and body weight not less than 50 kg at Screening.
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- Has resting vital signs at Screening within the following ranges: Systolic blood pressure (SBP) ≥100 mmHg Diastolic blood pressure (DBP) ≥50 mmHg Heart rate ≤100 beats per minute (bpm) Note: If vital signs are out of range, the Investigator may obtain two additional readings within the Screening period.
- Has a 12-lead ECG consistent with normal cardiac conduction and function at Screening, including: HR between 45 and 100 bpm (inclusive); QTcF ≤450 ms for males and ≤470 ms for females; QRS interval <120 ms; PR interval <220 ms; and morphology consistent with healthy cardiac conduction.
- Is a nonsmoker within the previous 6 months before Screening, and does not use tobacco containing, or nicotine-containing products, including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, e-cigarettes, nicotine patch, or nicotine gum.
- Has clinical chemistry, hematology, coagulation, and complete urinalysis (fasted for at least 8 hours) results at Screening within the reference range for the testing laboratory unless the out-of-range results are deemed not clinically significant by the Investigator.
- Has negative results for hepatitis B surface antigen (HbsAg) and hepatitis C virus antibody (HCV Ab) within 3 months prior to Day -1 or at Screening.
- Has negative test results for HIV antibody within 3 months prior to Day -1 or at Screening.
- Has a negative urine drug screen result at Screening and on Day -1. The presence of alcohol or marijuana in the urine is not exclusionary unless the Investigator determines that the participant's marijuana use qualifies as substance abuse (see Section 5.2, Exclusion Criteria 6).
- If individual's assigned sex at birth is female, they must be of non-childbearing potential based on either of the following: a. Is post-menopausal defined as amenorrhea for at least 12 months in absence of any exogenous hormonal treatments and follicle stimulating hormone (FSH) levels in the laboratory-defined postmenopausal range, or, b. Reports being surgically sterilized (i.e., tubal ligation, hysterectomy, bilateral oophorectomy/salpingectomy)
- If individual is assigned male sex at birth, is not sterilized, and is sexually active with a female partner of childbearing potential, agrees to use condoms from Day -1 through 90 days after the last dose of study drug. They must also agree to not donate sperm during the trial and for 3 months (90 days) after receiving the last dose of study drug.
Who cannot join
- If an individual meets any of the following criteria, they are ineligible for this trial:
- Has current or past history of a clinically significant cardiovascular, cerebrovascular, respiratory, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, as determined by the Investigator.
- Has history of or Screening findings of abnormalities of vision, including corrected visual acuity worse than 20/25 in either eye based on Screening assessment using Snellen chart and Rosenbaum pocket chart, or color vision impairment based on Screening assessment using Ishihara plates. Candidates with ametropia corrected to 20/25 or better do not have to be excluded.
- Has history of or Screening findings of peripheral neuropathy, such as numbness or abnormal reflexes.
- Has history of or current clinically relevant cardiovascular disorder, such as heart failure, coronary artery disease, uncontrolled hypertension, arrhythmia, tachyarrhythmia, prolonged QT syndrome, or presence of symptom(s) strongly suggestive of such a problem, such as exertional chest pressure/pain or unexplained syncope.
- Had an active malignancy within 5 years from Screening, except basal cell or squamous cell skin cancers. Any history of breast cancer or melanoma will be exclusionary.
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- Has history of any drug abuse within 1 year prior to Screening or has used any hard drugs (such as cocaine, phencyclidine [PCP], natural and synthetic opiates, and amphetamine derivatives) within 1 year prior to Screening. Individuals that have taken an opioid or amphetamine medication within the previous year prior to Screening that was prescribed by a healthcare provider will not be excluded unless they are currently taking the medication at the time of Screening.
- Has history of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces [150 mL)] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of Screening or alcohol abuse within 1 year prior to Screening.
- Had any surgical or medical condition or history that, in the opinion of the Investigator, may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to, gastric bypass or banding surgery or gastric or duodenal ulcers.
- Is taking any of the following prohibited medications or vaccinations: a. Any prescription or over-the-counter medication, vitamin or dietary supplement, or herbal product within 14 days prior to Day -1. b. Received any vaccination within 14 days prior to Day -1, including COVID-19 vaccination.
- Has a contraindication to study drugs or its excipients and/or history of a clinically significant allergic or anaphylactic reaction to a medication.
- Has participated in other trials involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before Screening for the current trial and during participation in the current trial.
- Has a positive PCR or antigen test result for COVID-19/SARS-CoV-2 at check-in to the Clinical Trials Unit.
- Has a condition that the Investigator believes would interfere with the participant's ability to provide written informed consent, comply with trial instructions, or which might confound the interpretation of the trial results or put the participant at undue risk.
- Has donated blood within 2 months before entering the trial or planning to donate blood during the trial or within 12 weeks after the final visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Trial in Healthy Adults to Evaluate the Safety, Tolerability, and PK of MK-7762
The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of single and then multiple doses of MK-7762 (TBD09) in healthy volunteers in the context of a first-in-human study. The effect of food on the rate and extent of absorption of a single oral dose of MK-7762 (TBD09) will also be evaluated.
Read the detailed description
This is a 2-part blinded, placebo-controlled, combined single ascending dose with a food effect cohort and multiple ascending dose trial to be conducted in one trial center in the United States.
Part 1 has a single ascending dose (SAD) design with up to 5 planned dose levels. Based on the interim PK results reviewed for the dose escalation decisions, a dose will be selected for administration to a sixth cohort both in fed and fasted states to evaluate the effect of food on MK-7762 (TBD09).
Safety will be assessed throughout the study; cardiac monitoring/serial ECGs and serial blood samples will be collected for the safety and PK assessment of MK7762 (TBD09). Dose escalation to the next cohort (i.e., dose level) will not take place until the Sponsor, in conjunction with the Principal Investigator, has determined that adequate safety, tolerability (and PK for the later cohorts) from the previous cohort has been demonstrated to permit proceeding to the next cohort.
Interim PK analyses will be performed for the dose escalation decisions (after cohorts 1 and 2 are completed), to select the intermediate dose for the food effect cohort, and to reconsider the sampling time points as the trial progresses. All samples will be sent for analysis and the bioanalytical lab will be unblinded and only run the analysis on active treatment participants. At the escalation meetings, PK analyses from active treatment participants and blinded (pooled) safety summaries will be reviewed.
All participants in Part 1 will remain at the trial site from Day -1 until their end of-trial visit (approximately 8 days for Cohorts 1-5 and 16 days for Cohort 6).
At the end of Part 1, pharmacokinetic and unblinded safety data along with dose rationale for Part 2 will be sent to the Food and Drug Administration (FDA) for review and approval. The trial will not proceed to Part 2 until the FDA provides approval.
Part 2 has a multiple ascending dose (MAD) design. The dose cohorts for Part 2 will be determined based on model predictions to determine the steady-state Cmax exposure, and safety from Part 1.
In this MAD part, each participant will be administered MK7762 or matching placebo for 28 days with corresponding PK measurements. Three dose cohorts are planned. After each dose cohort, the Sponsor and Investigator will review the PK and safety data before proceeding to the next dose level.
- Conditions
- Tuberculosis
- Being tested
- MK-7762 (TBD09), Placebo
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-7762 (TBD09)Drug
Cohort 1: 50 mg Cohort 2: 150 mg Cohort 3: 300 mg Cohort 4: 600 mg Cohort 5: TBD Cohort 6: TBD
PlaceboOther
A subset of participants from each of the 6 dosing cohorts will receive placebo.
| Study group | Role | What they receive |
|---|---|---|
| MK-7762 (TBD09) | Experimental | In Part 1 of the trial (SAD/FE), up to five sequential cohorts will be enrolled to evaluate up to five escalating single doses of MK-7762; 8 participants in each cohort will be randomized (3:1) to receive MK-7762 or placebo. A sixth cohort will evaluate the effect of food on PK of single doses of MK-7762 utilizing an open-label, two-period design in 8 participants. Receives: Drug: MK-7762 (TBD09) |
| Placebo | Placebo comparator | Participants will receive placebos matched to MK-7762 (TBD09). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Percentage of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor.
Measured: Day 1 through Day 7
Part 1: Percentage of Participants Reporting TEAEs by Severity
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal.
Measured: Day 1 through Day 7
Part 1: Percentage of Participants Reporting Study Drug Related TEAEs
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant.
Measured: Day 1 through Day 7
Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs, SAEs, and AESIs
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor.
Measured: Up to Day 7
Part 2: FE Cohort 7: Percentage of Participants Reporting Study Drug Related TEAEs
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant.
Measured: Up to Day 7
Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs by Severity
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal.
Measured: Up to Day 7
Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs, SAEs, and AESIs
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor.
Measured: Day 1 through Day 36.
Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs by Severity
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal.
Measured: Day 1 through Day 36.
Part 2: MAD Cohorts: Proportion of Participants Reporting Study Drug Related TEAEs
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant.
Measured: Day 1 through Day 36
Part 1: Number of Participants With Clinically Significant Changes in Hematology Parameters
Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and white blood cells [WBC]); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count
Measured: Up to Day 7
Part 1: Number of Participants With Clinically Significant Changes in Chemistry Parameters
Blood samples were collected for the analysis of chemistry parameters: alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total and direct bilirubin, creatinine, blood urea nitrogen (BUN) or urea, creatine kinase, sodium, potassium, bicarbonate or CO2, chloride, glucose, and lipid profile (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides.
Measured: Up to Day 7
Part 1: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters
Blood samples were collected for the analysis of Serum coagulation parameters: Prothrombin Time (PT), Partial Thromboplastin Time (PTT), and international normalized ratio (INR).
Measured: Up to Day 7
Part 1: Number of Participants With Clinically Significant Changes in Urinalysis
Urine samples were collected for the analysis of urinalysis parameters: Dipstick for potential of hydrogen (pH), specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites.
Measured: Up to Day 7
Part 1: Number of Participants With Clinically Significant Changes in Vital Parameters
Vital parameters including temperature, heart rate (HR), and blood pressure (BP) were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented.
Measured: Up to Day 7
Part 1: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected by Fridericia's formula (QTcF).
Measured: Up to Day 7
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Hematology Parameters
Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and WBC); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count.
Measured: Up to Day 8
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Hematology Parameters
Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and WBC); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count
Measured: Up to Day 36
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Chemistry Parameters
Blood samples were collected for the analysis of chemistry parameters: ALT, AST, ALP, total and direct bilirubin, creatinine, BUN or urea, creatine kinase, sodium, potassium, bicarbonate or CO2, chloride, glucose, and lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides).
Measured: Up to Day 8
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Chemistry Parameters
Participants were randomized to receive MK-7762 100 mg in a fed or fasted state.
Measured: Up to Day 36
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters
Blood samples were collected for the analysis of Serum coagulation parameters: PT, PTT, and INR.
Measured: Up to Day 8
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Urinalysis
Urine samples were collected for the analysis of urinalysis parameters: Dipstick for pH, specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites.
Measured: Up to Day 8
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters
Blood samples were collected for the analysis of Serum coagulation parameters: PT, PTT, and INR.
Measured: Up to Day 36
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Urinalysis
Urine samples were collected for the analysis of urinalysis parameters: Dipstick for pH, specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites
Measured: Up to Day 36
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Vital Parameters
Vital parameters including temperature, HR, and BP were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented.
Measured: Up to Day 8
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Vital Parameters
Vital parameters including temperature, HR, and BP were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented.
Measured: Up to Day 36
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in ECG Parameters
ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QTcF.
Measured: Up to Day 8
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in ECG Parameters
ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QTcF.
Measured: Up to Day 36
Secondary outcomes (26)
Part 1: Maximum Plasma Drug Concentration (Cmax) of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Measured: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1
Part 1: Time to Maximum Plasma Drug Concentration (Tmax) of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Measured: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1
Part 1: Area Under the Concentration-time Curve (AUC) Calculated to Last Quantifiable Observed Sample (AUClast) of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Measured: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1
Part 1: AUC Over First 24h (AUC0-24) of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Measured: Up to 24 hrs post dose
Part 1: AUC Extrapolated to Infinity (AUC0-inf) of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Measured: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1
Part 1: Terminal Elimination Half-life (t½) of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Measured: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1
Part 1: Oral Clearance (CL/F) of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Measured: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1
Part 1: Oral Volume of Distribution (Vd/F) of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Measured: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1
Part 2: FE Cohort 7: Cmax of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose
Part 2: FE Cohort 7: Tmax of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose
Part 2: FE Cohort 7: AUClast of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose
Part 2: FE Cohort 7: AUC0-inf of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose
Part 2: FE Cohort 7: AUC0-24 of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Up to 24 hours post dose
Part 2: FE Cohort 7: t½ of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose
Part 2: FE Cohort 7: CL/F of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose
Part 2: FE Cohort 7: Vd/F of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose
Part 2: MAD Cohorts: CL/F of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose
Part 2: MAD Cohorts: Vz/F of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose
Part 2: MAD Cohorts: Accumulation Ratio (RA AUC0-24) of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. Accumulation ratio based on AUC 0-24 was calculated as AUC tau (Day 28) /AUC 0-24 (Day 1).
Measured: Day 1: predose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose
Part 2: MAD Cohorts: Cmax of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdose
Part 2: MAD Cohorts: Tmax of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdose
Part 2: MAD Cohorts: AUC0-24 of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Up to 24 hours post dose
Part 2: MAD Cohorts: AUClast of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdose
Part 2: MAD Cohorts: AUC0-inf of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose
Part 2: MAD Cohorts: AUC0-24 of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 28: pre-dose, and at 1, 2, 4, 6, 8, 12 and 24 hours postdose
Part 2: MAD Cohorts: t1/2 of MK-7762
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Measured: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start23 Feb 2023
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gates Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Gates MRI, Study director, Gates MRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824091
- Sponsor's protocol ID
- Gates MRI-TBD09-101
- Status last verified
- May 2026
- First submitted
- 22 Mar 2023
- Last updated
- 4 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Trial in Healthy Adults to Evaluate the Safety, Tolerability, and PK of MK-7762
- ClinicalTrials.gov ID
- NCT05824091
- Acronym / sponsor ID
- Gates MRI-TBD09-101
- Conditions
- Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Gates Medical Research InstituteUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Posted 4 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of single and then multiple doses of MK-7762 (TBD09) in healthy volunteers in the context of a first-in-human study. The effect of food on the rate and extent of absorption of a single oral dose of MK-7762 (TBD09) will also be evaluated.
Detailed description
This is a 2-part blinded, placebo-controlled, combined single ascending dose with a food effect cohort and multiple ascending dose trial to be conducted in one trial center in the United States.
Part 1 has a single ascending dose (SAD) design with up to 5 planned dose levels. Based on the interim PK results reviewed for the dose escalation decisions, a dose will be selected for administration to a sixth cohort both in fed and fasted states to evaluate the effect of food on MK-7762 (TBD09).
Safety will be assessed throughout the study; cardiac monitoring/serial ECGs and serial blood samples will be collected for the safety and PK assessment of MK7762 (TBD09). Dose escalation to the next cohort (i.e., dose level) will not take place until the Sponsor, in conjunction with the Principal Investigator, has determined that adequate safety, tolerability (and PK for the later cohorts) from the previous cohort has been demonstrated to permit proceeding to the next cohort.
Interim PK analyses will be performed for the dose escalation decisions (after cohorts 1 and 2 are completed), to select the intermediate dose for the food effect cohort, and to reconsider the sampling time points as the trial progresses. All samples will be sent for analysis and the bioanalytical lab will be unblinded and only run the analysis on active treatment participants. At the escalation meetings, PK analyses from active treatment participants and blinded (pooled) safety summaries will be reviewed.
All participants in Part 1 will remain at the trial site from Day -1 until their end of-trial visit (approximately 8 days for Cohorts 1-5 and 16 days for Cohort 6).
At the end of Part 1, pharmacokinetic and unblinded safety data along with dose rationale for Part 2 will be sent to the Food and Drug Administration (FDA) for review and approval. The trial will not proceed to Part 2 until the FDA provides approval.
Part 2 has a multiple ascending dose (MAD) design. The dose cohorts for Part 2 will be determined based on model predictions to determine the steady-state Cmax exposure, and safety from Part 1.
In this MAD part, each participant will be administered MK7762 or matching placebo for 28 days with corresponding PK measurements. Three dose cohorts are planned. After each dose cohort, the Sponsor and Investigator will review the PK and safety data before proceeding to the next dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-7762 (TBD09) | Experimental | Drug: MK-7762 (TBD09)In Part 1 of the trial (SAD/FE), up to five sequential cohorts will be enrolled to evaluate up to five escalating single doses of MK-7762; 8 participants in each cohort will be randomized (3:1) to receive MK-7762 or placebo. A sixth cohort will evaluate the effect of food on PK of single doses of MK-7762 utilizing an open-label, two-period design in 8 participants. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive placebos matched to MK-7762 (TBD09). |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Is ≥ 19 to ≤ 55 years of age.
- Is healthy as determined by the Investigator via medical history and clinical examination before enrollment in the trial.
- Can understand and comply with the trial and site procedures, understand the risks involved in the trial, and provide written informed consent before the first trial-specific procedure.
- Can complete all Screening period evaluations and stay in the clinical research facility for the duration of the inpatient periods of the trial.
- Has BMI between 18 and 32 kg/m2, inclusive, and body weight not less than 50 kg at Screening.
Key exclusion criteria (15 listed)
- Has current or past history of a clinically significant cardiovascular, cerebrovascular, respiratory, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, as determined by the Investigator.
- Has history of or Screening findings of abnormalities of vision, including corrected visual acuity worse than 20/25 in either eye based on Screening assessment using Snellen chart and Rosenbaum pocket chart, or color vision impairment based on Screening assessment using Ishihara plates. Candidates with ametropia corrected to 20/25 or better do not have to be excluded.
- Has history of or Screening findings of peripheral neuropathy, such as numbness or abnormal reflexes.
- Has history of or current clinically relevant cardiovascular disorder, such as heart failure, coronary artery disease, uncontrolled hypertension, arrhythmia, tachyarrhythmia, prolonged QT syndrome, or presence of symptom(s) strongly suggestive of such a problem, such as exertional chest pressure/pain or unexplained syncope.
- Had an active malignancy within 5 years from Screening, except basal cell or squamous cell skin cancers. Any history of breast cancer or melanoma will be exclusionary.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-7762 (TBD09)Cohort 1: 50 mg Cohort 2: 150 mg Cohort 3: 300 mg Cohort 4: 600 mg Cohort 5: TBD Cohort 6: TBD | Drug | MK-7762 (TBD09) |
| PlaceboA subset of participants from each of the 6 dosing cohorts will receive placebo. | Other | Placebo |
Primary outcome
Part 1: Percentage of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Time frame: Day 1 through Day 7
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor.
Part 1: Percentage of Participants Reporting TEAEs by Severity
Time frame: Day 1 through Day 7
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal.
Part 1: Percentage of Participants Reporting Study Drug Related TEAEs
Time frame: Day 1 through Day 7
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant.
Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs, SAEs, and AESIs
Time frame: Up to Day 7
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor.
Part 2: FE Cohort 7: Percentage of Participants Reporting Study Drug Related TEAEs
Time frame: Up to Day 7
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant.
Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs by Severity
Time frame: Up to Day 7
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal.
Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs, SAEs, and AESIs
Time frame: Day 1 through Day 36.
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor.
Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs by Severity
Time frame: Day 1 through Day 36.
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal.
Part 2: MAD Cohorts: Proportion of Participants Reporting Study Drug Related TEAEs
Time frame: Day 1 through Day 36
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant.
Part 1: Number of Participants With Clinically Significant Changes in Hematology Parameters
Time frame: Up to Day 7
Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and white blood cells [WBC]); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count
Part 1: Number of Participants With Clinically Significant Changes in Chemistry Parameters
Time frame: Up to Day 7
Blood samples were collected for the analysis of chemistry parameters: alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total and direct bilirubin, creatinine, blood urea nitrogen (BUN) or urea, creatine kinase, sodium, potassium, bicarbonate or CO2, chloride, glucose, and lipid profile (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides.
Part 1: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters
Time frame: Up to Day 7
Blood samples were collected for the analysis of Serum coagulation parameters: Prothrombin Time (PT), Partial Thromboplastin Time (PTT), and international normalized ratio (INR).
Part 1: Number of Participants With Clinically Significant Changes in Urinalysis
Time frame: Up to Day 7
Urine samples were collected for the analysis of urinalysis parameters: Dipstick for potential of hydrogen (pH), specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites.
Part 1: Number of Participants With Clinically Significant Changes in Vital Parameters
Time frame: Up to Day 7
Vital parameters including temperature, heart rate (HR), and blood pressure (BP) were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented.
Part 1: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Up to Day 7
ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected by Fridericia's formula (QTcF).
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Hematology Parameters
Time frame: Up to Day 8
Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and WBC); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count.
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Hematology Parameters
Time frame: Up to Day 36
Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and WBC); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Chemistry Parameters
Time frame: Up to Day 8
Blood samples were collected for the analysis of chemistry parameters: ALT, AST, ALP, total and direct bilirubin, creatinine, BUN or urea, creatine kinase, sodium, potassium, bicarbonate or CO2, chloride, glucose, and lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides).
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Chemistry Parameters
Time frame: Up to Day 36
Participants were randomized to receive MK-7762 100 mg in a fed or fasted state.
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters
Time frame: Up to Day 8
Blood samples were collected for the analysis of Serum coagulation parameters: PT, PTT, and INR.
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Urinalysis
Time frame: Up to Day 8
Urine samples were collected for the analysis of urinalysis parameters: Dipstick for pH, specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites.
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters
Time frame: Up to Day 36
Blood samples were collected for the analysis of Serum coagulation parameters: PT, PTT, and INR.
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Urinalysis
Time frame: Up to Day 36
Urine samples were collected for the analysis of urinalysis parameters: Dipstick for pH, specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Vital Parameters
Time frame: Up to Day 8
Vital parameters including temperature, HR, and BP were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented.
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Vital Parameters
Time frame: Up to Day 36
Vital parameters including temperature, HR, and BP were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented.
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in ECG Parameters
Time frame: Up to Day 8
ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QTcF.
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in ECG Parameters
Time frame: Up to Day 36
ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QTcF.
26 secondary outcomes
Part 1: Maximum Plasma Drug Concentration (Cmax) of MK-7762
Time frame: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1
Part 1: Time to Maximum Plasma Drug Concentration (Tmax) of MK-7762
Time frame: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1
Part 1: Area Under the Concentration-time Curve (AUC) Calculated to Last Quantifiable Observed Sample (AUClast) of MK-7762
Time frame: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1
Part 1: AUC Over First 24h (AUC0-24) of MK-7762
Time frame: Up to 24 hrs post dose
Part 1: AUC Extrapolated to Infinity (AUC0-inf) of MK-7762
Time frame: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1
Part 1: Terminal Elimination Half-life (t½) of MK-7762
Time frame: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1
Part 1: Oral Clearance (CL/F) of MK-7762
Time frame: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1
Part 1: Oral Volume of Distribution (Vd/F) of MK-7762
Time frame: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1
Part 2: FE Cohort 7: Cmax of MK-7762
Time frame: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose
Part 2: FE Cohort 7: Tmax of MK-7762
Time frame: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose
Part 2: FE Cohort 7: AUClast of MK-7762
Time frame: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose
Part 2: FE Cohort 7: AUC0-inf of MK-7762
Time frame: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose
Part 2: FE Cohort 7: AUC0-24 of MK-7762
Time frame: Up to 24 hours post dose
Part 2: FE Cohort 7: t½ of MK-7762
Time frame: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose
Part 2: FE Cohort 7: CL/F of MK-7762
Time frame: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose
Part 2: FE Cohort 7: Vd/F of MK-7762
Time frame: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose
Part 2: MAD Cohorts: CL/F of MK-7762
Time frame: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose
Part 2: MAD Cohorts: Vz/F of MK-7762
Time frame: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose
Part 2: MAD Cohorts: Accumulation Ratio (RA AUC0-24) of MK-7762
Time frame: Day 1: predose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose
Part 2: MAD Cohorts: Cmax of MK-7762
Time frame: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdose
Part 2: MAD Cohorts: Tmax of MK-7762
Time frame: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdose
Part 2: MAD Cohorts: AUC0-24 of MK-7762
Time frame: Up to 24 hours post dose
Part 2: MAD Cohorts: AUClast of MK-7762
Time frame: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdose
Part 2: MAD Cohorts: AUC0-inf of MK-7762
Time frame: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose
Part 2: MAD Cohorts: AUC0-24 of MK-7762
Time frame: Day 28: pre-dose, and at 1, 2, 4, 6, 8, 12 and 24 hours postdose
Part 2: MAD Cohorts: t1/2 of MK-7762
Time frame: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gates MRI study director
Gates MRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-7762 (TBD09) in people with Tuberculosis, run by Gates Medical Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Percentage of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) (time frame: Day 1 through Day 7). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.