TQT StudyPhase 1NCT04238195
A Single-Dose, Randomized, Placebo- and Active-Control, Four-Way, Cross-Over Study for the Evaluation of the Effect of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) on the QT/QTc Intervals in Adult Healthy Subjects
A Phase 1 study testing Moxifloxacin 400mg and Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in people with TQT Study, run by Spero Therapeutics at 1 site in United States.
Trial summary
This is a randomized, double-blind (with respect to Tebipenem pivoxil hydrobromide [TBPM-PI-HBr]/placebo only), placebo- and active-control, single-dose, 4-way crossover study that will enroll 24 healthy adult male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- TQT Study
- What is being tested?
- Moxifloxacin 400mg and Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2020to 26 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
- Healthy, adult, male or female, 18-65 years of age, inclusive, at screening.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study, based on subject self- reporting.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- No clinically significant history or presence of ECG findings as judged by the PI or qualified designee at screening and prior to dosing of Period 1, including each criterion as listed below:
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- Normal sinus rhythm (heart rate between 50 and 100 bpm, inclusive);
- QTcF interval (Fridericia's correction to the QT interval) ≤ 450 msec;
- QRS interval < 110 msec;
- PR interval < 220 msec.
- For a female of childbearing potential: either be sexually inactive (abstinent as a lifestyle) for 3 months prior to the first dosing and throughout the study or be using one of the following acceptable birth control methods:
- non-hormone releasing intrauterine device for at least 3 months prior to the first dosing and throughout the study.
- surgical sterilization of the partner (vasectomy for 4 months minimum prior to the first dosing. In addition, female subjects of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for at least 28 days following the last dose.
- For a female of non-childbearing potential: must have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
- hysteroscopic sterilization (with confirmation of procedure success with hystosalpingogram);
- bilateral tubal ligation or bilateral salpingectomy;
- hysterectomy;
- bilateral oophorectomy;
- or be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and have follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
- A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after the last dosing.
- (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to the first dosing of study drug. A male who has been vasectomized less than 4 months prior to study first dosing must follow the same restrictions as a non-vasectomized male).
- If male, must agree not to donate sperm from the first dosing until 90 days after the last dosing.
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Who cannot join
- Subjects must not be enrolled in the study if they meet any of the following criteria:
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds (especially fluoroquinolone-, carbapenem-, penicillin-, and cephalosporin-antibiotics sensitivity).
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- History or presence of any of the following, deemed clinically significant by the PI or designee:
- Ventricular pre-excitation syndrome (Wolff-Parkinson White syndrome);
- Arrhythmia or history of arrhythmia requiring medical intervention;
- Risk factors for Torsade de Pointes (e.g., heart failure, cardiomyopathy, or family history of Long QT Syndrome);
- Sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities.
- Allergy to ECG electrode adhesive patches, band aids, adhesive dressing or medical tape.
- History of epilepsy or seizure disorder.
- History of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic acidemia).
- Female subjects with a positive pregnancy test or who are lactating.
- Positive urine drug or alcohol results at screening or first check-in.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
- Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
- Estimated creatinine clearance <80 mL/min at screening.
- Unable to refrain from or anticipates the use of the following drugs beginning 14 days prior to the first dosing and throughout the study:
- Any drug, including prescription and non-prescription medications , herbal remedies, or vitamin supplements. After first dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee.
- Any gastric acid-reducing medications, including but not limited to proton pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole), histamine-2 receptor antagonists (e.g., nizatidine, famotidine, cimetidine, ranitidine), and antacids (e.g., Alka-Seltzer, Milk of Magnesia, Amphojel, Gelusil, Maalox, Mylanta, Rolaids, Pepto-Bismol).
- Valproic acid or divalproex sodium.
- Probenecid.
- Has been on a diet incompatible with the on-study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing and throughout the study.
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
- Participation in another clinical study within 30 days prior to the first dosing. The 30- day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, double-blind (with respect to Tebipenem pivoxil hydrobromide [TBPM-PI-HBr]/placebo only), placebo- and active-control, single-dose, 4-way crossover study that will enroll 24 healthy adult male and female subjects. There will be a washout period of at least 7 days between dosing in each period and each subject will receive all 4 treatments over 4 periods in a crossover study design.
Read the detailed description
This is a randomized, double-blind (with respect to TBPM-PI-HBr / placebo only), placebo- and active-control, single-dose, 4-way crossover study. Twenty-four (24) healthy, adult, male and female subjects will be enrolled. Screening of subjects will occur within 28 days prior to the first dosing.
All subjects will receive a single dose of 4 different study treatments over 4 separate treatment periods, each separated by a 7-day washout period.
On Day 1 of Period 1, subjects will be randomized to 1 of 12 treatment sequences. Sentinel group: In Period 1 only, 4 subjects will be dosed 24 hours prior to the remaining 20 subjects. Each of the 4 subjects from the sentinel group will receive a different treatment.
On Day 1 of each period, subjects will receive a single oral therapeutic dose of TBPM-PI-HBr (Treatment A), supratherapeutic dose of TBPM-PI-HBr (Treatment B), placebo (Treatment C), or moxifloxacin (Treatment D) according to the randomization scheme.
In each period, cardiodynamic ECGs and PK blood samples will be collected pre-dose and for 24 hours post-dose. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.
Discontinued subjects who have received study drug will not be replaced.
- Conditions
- TQT Study
- Being tested
- Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + Placebo, Moxifloxacin 400mg, Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr), Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)
- Keywords
- TQT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + PlaceboDrug
Also called SPR994
Treatment A: Subjects receive TBPM-PI-HBr + matching Placebo.
Moxifloxacin 400mgDrug
Also called Avelox
Treatment D: Subjects receive 1 400 mg tablet of moxifloxacin administered in an open label manner.
Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)Other
Treatment C: Subjects receive TBPM-PI-HBr matching placebo.
Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)Drug
Also called SPR994
Treatment B: Subjects receive TBPM-PI-HBr.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 600 mg TBPM-PI-HBr (2 x 300 mg tablets) and TBPM-PI-HBr-matching placebo (2 x matching placebo tablets) administered at Hour 0 on Day 1. Receives: Drug: Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + Placebo; Other: Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) |
| Treatment B | Experimental | 1200 mg TBPM-PI-HBr (4 x 300 mg tablets) administered at Hour 0 on Day 1. Receives: Drug: Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) |
| Treatment C | Placebo comparator | TBPM-PI-HBr-matching placebo (4 x matching placebo tablets) administered at Hour 0 on Day 1. Receives: Other: Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) |
| Treatment D | Other | Positive Control - unblinded: 400 mg moxifloxacin (1 x 400 mg tablet) administered at Hour 0 on Day 1. Receives: Drug: Moxifloxacin 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on the heart rate corrected QT interval (QTc) by assessing concentration-QT (C-QT) relationship using exposure-response modeling.
Holter monitors will be used to collect continuous 12-lead electrocardiogram (ECG) data on Day 1. Triplicate 10-second, 12-lead ECG recordings will be extracted from the Holter monitor data within a 5-minute time window prior to the pharmacokinetic (PK) blood samples collected as close to the exact time point as possible
Measured: Pre-dose through 24 hours post-dose
Secondary outcomes (14)
1. To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on other electrocardiogram (ECG) parameters.
Number of participants with changes in QTc from baseline.
Measured: Pre-dose through 24 hours post-dose
1. To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on other electrocardiogram (ECG) parameters.
Number of participants with changes in QT from baseline.
Measured: Pre-dose through 24 hours post-dose
1. To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on other electrocardiogram (ECG) parameters.
Number of participants with changes in PR interval from baseline.
Measured: Pre-dose through 24 hours post-dose
1. To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on other electrocardiogram (ECG) parameters.
Number of participants with changes in RR interval from baseline.
Measured: Pre-dose through 24 hours post-dose
1. To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on other electrocardiogram (ECG) parameters.
Number of participants with changes in QRS duration from baseline.
Measured: Pre-dose through 24 hours post-dose
1. To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on other electrocardiogram (ECG) parameters.
Number of participants with changes in heart rate (HR) from baseline.
Measured: Pre-dose through 24 hours post-dose
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
AUC0-last will be calculated for TBPM and moxifloxacin in plasma.
Measured: Pre-dose through 24 hours post-dose
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
AUC0-inf will be calculated for TBPM and moxifloxacin in plasma.
Measured: Pre-dose through 24 hours post-dose
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
AUC%extrap will be calculated for TBPM and moxifloxacin in plasma.
Measured: Pre-dose through 24 hours post-dose
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
Cmax will be calculated for TBPM and moxifloxacin in plasma.
Measured: Pre-dose through 24 hours post-dose
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
Tmax will be calculated for TBPM and moxifloxacin in plasma.
Measured: Pre-dose through 24 hours post-dose
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
Kel will be calculated for TBPM and moxifloxacin in plasma.
Measured: Pre-dose through 24 hours post-dose
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
t1/2 will be calculated for TBPM and moxifloxacin in plasma.
Measured: Pre-dose through 24 hours post-dose
3. To assess the safety and tolerability of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
Number of participants with treatment-related adverse events using CTCAE v5.0.
Measured: Pre-dose through 24 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 posted23 Jan 2020
- Study start19 Jan 2020
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TQT StudyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Over 4 separate treatment periods, each separated by a 7-day washout period, all subjects will receive a single dose of 4 different study treatments.The design is constructed from three 4x4 Latin Squares balanced for carry-over effects.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spero Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238195
- Sponsor's protocol ID
- SPR994-104
- Status last verified
- Mar 2020
- First submitted
- 16 Jan 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Randomized, Placebo- and Active-Control, Four-Way, Cross-Over Study for the Evaluation of the Effect of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) on the QT/QTc Intervals in Adult Healthy Subjects
- ClinicalTrials.gov ID
- NCT04238195
- Acronym / sponsor ID
- SPR994-104
- Conditions
- TQT Study
- Keywords
- TQT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Spero TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 19 Jan 2020 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind (with respect to Tebipenem pivoxil hydrobromide [TBPM-PI-HBr]/placebo only), placebo- and active-control, single-dose, 4-way crossover study that will enroll 24 healthy adult male and female subjects. There will be a washout period of at least 7 days between dosing in each period and each subject will receive all 4 treatments over 4 periods in a crossover study design.
Detailed description
This is a randomized, double-blind (with respect to TBPM-PI-HBr / placebo only), placebo- and active-control, single-dose, 4-way crossover study. Twenty-four (24) healthy, adult, male and female subjects will be enrolled. Screening of subjects will occur within 28 days prior to the first dosing.
All subjects will receive a single dose of 4 different study treatments over 4 separate treatment periods, each separated by a 7-day washout period.
On Day 1 of Period 1, subjects will be randomized to 1 of 12 treatment sequences. Sentinel group: In Period 1 only, 4 subjects will be dosed 24 hours prior to the remaining 20 subjects. Each of the 4 subjects from the sentinel group will receive a different treatment.
On Day 1 of each period, subjects will receive a single oral therapeutic dose of TBPM-PI-HBr (Treatment A), supratherapeutic dose of TBPM-PI-HBr (Treatment B), placebo (Treatment C), or moxifloxacin (Treatment D) according to the randomization scheme.
In each period, cardiodynamic ECGs and PK blood samples will be collected pre-dose and for 24 hours post-dose. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.
Discontinued subjects who have received study drug will not be replaced.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Over 4 separate treatment periods, each separated by a 7-day washout period, all subjects will receive a single dose of 4 different study treatments.The design is constructed from three 4x4 Latin Squares balanced for carry-over effects.
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + Placebo, Other: Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)600 mg TBPM-PI-HBr (2 x 300 mg tablets) and TBPM-PI-HBr-matching placebo (2 x matching placebo tablets) administered at Hour 0 on Day 1. |
| Treatment B | Experimental | Drug: Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)1200 mg TBPM-PI-HBr (4 x 300 mg tablets) administered at Hour 0 on Day 1. |
| Treatment C | Placebo comparator | Other: Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)TBPM-PI-HBr-matching placebo (4 x matching placebo tablets) administered at Hour 0 on Day 1. |
| Treatment D | Other | Drug: Moxifloxacin 400mgPositive Control - unblinded: 400 mg moxifloxacin (1 x 400 mg tablet) administered at Hour 0 on Day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
- Healthy, adult, male or female, 18-65 years of age, inclusive, at screening.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study, based on subject self- reporting.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
Key exclusion criteria (29 listed)
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds (especially fluoroquinolone-, carbapenem-, penicillin-, and cephalosporin-antibiotics sensitivity).
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 |
|---|---|---|
| Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + PlaceboAlso: SPR994Treatment A: Subjects receive TBPM-PI-HBr + matching Placebo. | Drug | Treatment A |
| Moxifloxacin 400mgAlso: AveloxTreatment D: Subjects receive 1 400 mg tablet of moxifloxacin administered in an open label manner. | Drug | Treatment D |
| Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)Treatment C: Subjects receive TBPM-PI-HBr matching placebo. | Other | Treatment A, Treatment C |
| Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)Also: SPR994Treatment B: Subjects receive TBPM-PI-HBr. | Drug | Treatment B |
Primary outcome
To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on the heart rate corrected QT interval (QTc) by assessing concentration-QT (C-QT) relationship using exposure-response modeling.
Time frame: Pre-dose through 24 hours post-dose
Holter monitors will be used to collect continuous 12-lead electrocardiogram (ECG) data on Day 1. Triplicate 10-second, 12-lead ECG recordings will be extracted from the Holter monitor data within a 5-minute time window prior to the pharmacokinetic (PK) blood samples collected as close to the exact time point as possible
14 secondary outcomes
1. To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on other electrocardiogram (ECG) parameters.
Time frame: Pre-dose through 24 hours post-dose
1. To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on other electrocardiogram (ECG) parameters.
Time frame: Pre-dose through 24 hours post-dose
1. To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on other electrocardiogram (ECG) parameters.
Time frame: Pre-dose through 24 hours post-dose
1. To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on other electrocardiogram (ECG) parameters.
Time frame: Pre-dose through 24 hours post-dose
1. To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on other electrocardiogram (ECG) parameters.
Time frame: Pre-dose through 24 hours post-dose
1. To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on other electrocardiogram (ECG) parameters.
Time frame: Pre-dose through 24 hours post-dose
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
Time frame: Pre-dose through 24 hours post-dose
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
Time frame: Pre-dose through 24 hours post-dose
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
Time frame: Pre-dose through 24 hours post-dose
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
Time frame: Pre-dose through 24 hours post-dose
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
Time frame: Pre-dose through 24 hours post-dose
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
Time frame: Pre-dose through 24 hours post-dose
2. To evaluate pharmacokinetics (PK) of tebipenem (TBPM) after administration of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
Time frame: Pre-dose through 24 hours post-dose
3. To assess the safety and tolerability of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr.
Time frame: Pre-dose through 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Moxifloxacin 400mg and Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in people with TQT Study, run by Spero Therapeutics 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 23 inclusion and 29 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 13 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the effect of a single therapeutic and supratherapeutic dose of TBPM-PI-HBr on the heart rate corrected QT interval (QTc) by assessing concentration-QT (C-QT) relationship using exposure-response modeling. (time frame: Pre-dose through 24 hours post-dose). 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 13 Mar 2020.