HealthyPhase 1NCT05074134
Absorption, Metabolism, and Excretion Study of [14C]-TNP-2092
A Phase 1 study testing [14C]-TNP-2092 in people with Healthy, run by TenNor Therapeutics Limited at 1 site in United States.
Trial summary
This is an open-label, single dose, Phase 1 study conducted at a single study center in the United States (USA). This study will evaluate the absorption, metabolism and elimination (AME), mass balance, safety and tolerability of a single dose of intravenously administered [14C]-TNP-2092. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]-TNP-2092
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2021to 12 Jul 2022
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of understanding the written informed consent form (ICF), willingly provide valid, signed written informed consent, and willing and able to comply with the schedule, requirements, and restrictions of the study
- Males between 18 and 55 years of age (inclusive) at the time of Screening
- Body mass index (BMI) ≥18.0 kg/m2 and ≤32.0 kg/m2 at Screening; body weight ≥55.0 kg and ≤100.0 kg at Screening
- Considered to be in good health by the Investigator, as determined by medical history, physical examination, VS measurements, 12-lead ECG, and clinical laboratory test results
- Male subjects with female sexual partner(s) of reproductive potential may be enrolled if the male:
- is documented to be surgically sterile (i.e., successfully vasectomized), or
Show all 12Show fewer
- agrees to use 2 methods of highly effective contraception and agree to refrain from sperm donation from the time of Screening through 90 days post dose
- Negative serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), and human immunodeficiency virus antibody (HIV Ab)
- Non-smoker (with no use of other tobacco or nicotine containing products, in any form), as documented by history (no nicotine within 6 months prior to Screening) and a negative cotinine test at Screening and Admission See Section 5.3 for details of nicotine and tobacco restrictions
- Negative results for drugs of abuse and alcohol at Screening and Admission
- Content of 14C in urine, whole blood, and/or plasma (per Investigator discretion) samples obtained at Screening does not significantly exceed the general environmental background 14C level At present, background level of 14C is 104 percent Modern Carbon (pMC). To be eligible for study enrollment, subjects must have ≤30 pMC in a plasma or urine sample analyzed with sodium benzoate carbon carrier or ≤150 pMC for a sample analyzed directly (with no carbon carrier).
- Willing to comply with Pharmaron's COVID-19 policies.
Who cannot join
- Any contraindication to the use of rifampin/rifamycin or a fluoroquinolone
- History or presence of any condition (e.g., chronic diarrhea) or prior surgery (e.g., gastric bypass) that, in the opinion of the Investigator, poses a significant risk to subject safety and/or achievement of study objectives
- Clinically significant abnormal medical history, or any abnormal findings on physical examination, VS, ECG, or laboratory tests at Screening, Admission, or pre dose on Day 1 that, in the opinion of the Investigator, could jeopardize achieving the study objectives and/or compromise the subject's safety
- History of cancer that has not been in full remission for >5 years (except basal cell skin cancer or squamous cell skin cancer with history of curative treatment and no recurrence for >1 year prior to Screening), as judged by the Investigator
- Acute illness within 14 days prior to study drug administration on Day 1, unless mild in severity and enrollment is approved by both the Investigator and Sponsor's medical representative
- COVID-19 positive for active disease
Show all 28Show fewer
- Any history of allergic drug reactions
- History or presence of alcohol or drug abuse within 2 years prior to Screening
- Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void
- Usual habit of <1 or >3 bowel movements per day
- Exposure to radiation for therapeutic or diagnostic reasons (except dental X rays and plain X rays of thorax and bony skeleton) within the past 12 months prior to study drug administration on Day 1, or worker occupationally exposed to radiation
- Participation in another clinical study in which a [14C] labeled drug was administered within 1 year prior to Admission
- Administration of another investigational medication within 30 days (or 5 half lives, whichever is longer) prior to study drug administration
- Participation in an investigational device study within 30 days prior to study drug administration
- Any ECG abnormality considered to be clinically significant by the Investigator
- QTcF interval (QT interval corrected for heart rate per Fridericia's formula) >450 msec at Screening, Admission, or pre dose on Day 1
- Family history of long QT syndrome or of unexplained sudden death in a first-degree relative under 50 years of age
- Documented congenital or acquired long QT syndrome
- Glomerular filtration rate (GFR) ≤80 mL/min/1.73 m2, as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation
- Presence of clinically significant hypertension, defined as systolic blood pressure (SBP) >140 mmHg and/or diastolic blood pressure (DBP) >90 mmHg, at Screening or Admission
- Presence of clinically significant hypotension, defined as SBP <90 mmHg and/or DBP <50 mmHg, at Screening or Admission
- Loss or donation of blood (approximately 500 mL) within 60 days prior to study drug administration on Day 1; donation of bone marrow or peripheral stem cells within 90 days prior to study drug administration on Day 1; or donation of plasma within 30 days prior to study drug administration on Day 1
- Excessive consumption of alcohol, defined as >3 alcoholic beverages per day (12 ounces of beer [354 mL], 5 ounces of wine [148 mL] or 1.5 ounce of distilled spirits [44 mL] is approximately equivalent to 1 alcoholic beverage)
- Excessive consumption of coffee, tea, cola or other caffeinated beverages; excessive consumption is defined as >6 servings per day (1 serving contains approximately 120 mg caffeine)
- Venous access considered inadequate for PK sample collection; history or evidence of adverse symptoms associated with phlebotomy or blood donation
- Employee or family member of the Investigator, study site personnel or Sponsor
- Use/consumption of any medications or substances listed as prohibited
- Any other reason that, in the opinion of the Investigator, would render the subject unsuitable for study enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaron Clinical Pharmacology Center
Baltimore, Maryland, 21201
About this study
Official title: An Open Label Phase 1 Study in Healthy Adult Male Subjects to Investigate the Absorption, Metabolism, and Excretion of [14C]-TNP-2092 Following a Single Intravenous Dose Administration
This is an open-label, single dose, Phase 1 study conducted at a single study center in the United States (USA). This study will evaluate the absorption, metabolism and elimination (AME), mass balance, safety and tolerability of a single dose of intravenously administered [14C]-TNP-2092.
Healthy men aged 18 to 55, will be screened, and subjects who meet all eligibility criteria and provide written informed consent will be enrolled into the study within 28 days of Screening.
Read more
Subjects will be admitted to the clinical unit on the day prior to dosing (Day -1). Subjects will fast overnight and then given a standard breakfast 30 min prior to dosing.
Six subjects will be enrolled in the study and each will receive a single intravenous (IV) dose of 300 mg/3 μCi [14C]-TNP-2092 administered over 60 minutes (±10 minutes).
Read the detailed description
This is an open-label, single dose, Phase 1 study conducted at a single study center in the United States (USA). This study will evaluate the absorption, metabolism and elimination (AME), mass balance, safety and tolerability of a single dose of intravenously administered [14C]-TNP-2092 Healthy men aged 18 to 55, will be screened, and subjects who meet all eligibility criteria and provide written informed consent will be enrolled into the study within 28 days of Screening.
Subjects will be admitted to the clinical unit on the day prior to dosing (Day 1). Subjects will fast overnight and then given a standard breakfast 30 min prior to dosing.
Six subjects will be enrolled in the study and each will receive a single intravenous (IV) dose of 300 mg/3 µCi [14C]-TNP-2092 administered over 60 minutes (±10 minutes).
Subjects will remain in the unit for 7 days after dosing (until morning of Day 8) for observation and collection of whole blood, urine and fecal samples.
Whole blood samples will be collected at pre-dose (-30 minutes) and at 15 minutes, 30 minutes, 45 minutes, 1 h (end of infusion), and at 1 h 5 minutes, 1 h 10 minutes, 1 h 15 minutes, 1 h 30 minutes, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours after initiation of the [14C]-TNP-2092 infusion (n=25 timepoints per subject). Depending on 14C radiolabel recovery, an additional whole blood sample may be collected on Day 15 (336 hours after initiation dosing) for a total of n=26 timepoints per subject. These samples will be used to determine concentrations of TNP-2092 (in plasma), metabolite profiling (in plasma), and total [14C] (whole blood and plasma).
Urine will be continuously collected for [14C] recovery, and metabolite assessments from the time of admission until immediately prior to dosing (pre dose) and over the following collection intervals: 0-8, 8-16, 16-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours (Day 8) after initiation of the [14C]-TNP 2092 infusion (n=10 timepoints per subject). Depending on 14C radiolabel recovery, additional urine samples may be collected on Days 14 and 15 (312-336 hours after dosing).
Feces will be continuously collected for metabolite and [14C] recovery assessments from the time of admission until immediately prior to dosing (pre dose) and over the following collection intervals: 0-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours (Day 8) after initiation of the [14C]-TNP-2092 infusion (n=8 timepoints per subject). Depending on 14C radiolabel recovery, additional fecal samples may be collected on Days 14 and 15 (312-336 hours after dosing).
Safety will be assessed by physical examination, vital signs (VS), 12-lead electrocardiograms, clinical laboratory tests (serum chemistry panel, hematology, coagulation, and urinalysis), use of concomitant medications, collection of adverse events, and by unscheduled assessments as needed for management of adverse events.
Subjects will be discharged from the CPC on Day 8 after completion of all 168h timepoint assessments. The Investigator will indicate whether ≥90% of the 14C radiolabel has been recovered in samples collected through 168h; if so, Day 8 will be the final study visit. If recovery of 14C in excreta is <90% by the time of discharge on Day 8, subjects will return to the site for an additional 24-hour PK confinement period on Days 14-15 (312-336h). The date of study completion for each subject will be defined as the last day that PK samples are collected. To avoid enrolling a participant with systemic 14C excess, samples of urine and/or blood (either whole blood or plasma) obtained at Screening must show no significant excess of 14C over environmental background level.
- Conditions
- Healthy
- Being tested
- [14C]-TNP-2092
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-TNP-2092Drug
Subjects will receive a single intravenous (IV) dose of 300 mg/3 µCi [14C]-TNP-2092 administered over 60 minutes (± 10 minutes).
| Study group | Role | What they receive |
|---|---|---|
| [14C]-TNP-2092 | Experimental | Not described Receives: Drug: [14C]-TNP-2092 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance of TNP-2092 and the percentages of radiolabel recovered in urine and feces
Percent (%) for each radiolabeled drug-related material will be determined in plasma,urine and feces.
Measured: Day 7
Pharmacokinetics (PK) of TNP-2092 in plasma
AUC(Area under the plasma concentration) will be determined, using Linear/Log trapezoidal method, from plasma concentration data for TNP-2092
Measured: Day 7
Pharmacokinetics (PK) of TNP-2092 in plasma
t1/2 (apparent terminal elimination half life) will be estimated for TNP-2092 from the terminal portion of its plasma concentration versus time plot
Measured: Day 7
Secondary outcomes (1)
Routes and rates of elimination of [14C] TNP 2092
Recovery (as % administered dose) of total radioactivity in urine and feces.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start16 Oct 2021
- Primary completion30 Nov 2021
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- TenNor Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074134
- Sponsor's protocol ID
- TNP-2092-IV-08
- Status last verified
- Oct 2022
- First submitted
- 29 Sep 2021
- Last updated
- 19 Oct 2022
- 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 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 1 Study in Healthy Adult Male Subjects to Investigate the Absorption, Metabolism, and Excretion of [14C]-TNP-2092 Following a Single Intravenous Dose Administration
- ClinicalTrials.gov ID
- NCT05074134
- Acronym / sponsor ID
- TNP-2092-IV-08
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- TenNor Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 12 Oct 2021 (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 an open-label, single dose, Phase 1 study conducted at a single study center in the United States (USA). This study will evaluate the absorption, metabolism and elimination (AME), mass balance, safety and tolerability of a single dose of intravenously administered [14C]-TNP-2092.
Healthy men aged 18 to 55, will be screened, and subjects who meet all eligibility criteria and provide written informed consent will be enrolled into the study within 28 days of Screening.
Subjects will be admitted to the clinical unit on the day prior to dosing (Day -1). Subjects will fast overnight and then given a standard breakfast 30 min prior to dosing.
Six subjects will be enrolled in the study and each will receive a single intravenous (IV) dose of 300 mg/3 μCi [14C]-TNP-2092 administered over 60 minutes (±10 minutes).
Detailed description
This is an open-label, single dose, Phase 1 study conducted at a single study center in the United States (USA). This study will evaluate the absorption, metabolism and elimination (AME), mass balance, safety and tolerability of a single dose of intravenously administered [14C]-TNP-2092 Healthy men aged 18 to 55, will be screened, and subjects who meet all eligibility criteria and provide written informed consent will be enrolled into the study within 28 days of Screening.
Subjects will be admitted to the clinical unit on the day prior to dosing (Day 1). Subjects will fast overnight and then given a standard breakfast 30 min prior to dosing.
Six subjects will be enrolled in the study and each will receive a single intravenous (IV) dose of 300 mg/3 µCi [14C]-TNP-2092 administered over 60 minutes (±10 minutes).
Subjects will remain in the unit for 7 days after dosing (until morning of Day 8) for observation and collection of whole blood, urine and fecal samples.
Whole blood samples will be collected at pre-dose (-30 minutes) and at 15 minutes, 30 minutes, 45 minutes, 1 h (end of infusion), and at 1 h 5 minutes, 1 h 10 minutes, 1 h 15 minutes, 1 h 30 minutes, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours after initiation of the [14C]-TNP-2092 infusion (n=25 timepoints per subject). Depending on 14C radiolabel recovery, an additional whole blood sample may be collected on Day 15 (336 hours after initiation dosing) for a total of n=26 timepoints per subject. These samples will be used to determine concentrations of TNP-2092 (in plasma), metabolite profiling (in plasma), and total [14C] (whole blood and plasma).
Urine will be continuously collected for [14C] recovery, and metabolite assessments from the time of admission until immediately prior to dosing (pre dose) and over the following collection intervals: 0-8, 8-16, 16-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours (Day 8) after initiation of the [14C]-TNP 2092 infusion (n=10 timepoints per subject). Depending on 14C radiolabel recovery, additional urine samples may be collected on Days 14 and 15 (312-336 hours after dosing).
Feces will be continuously collected for metabolite and [14C] recovery assessments from the time of admission until immediately prior to dosing (pre dose) and over the following collection intervals: 0-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours (Day 8) after initiation of the [14C]-TNP-2092 infusion (n=8 timepoints per subject). Depending on 14C radiolabel recovery, additional fecal samples may be collected on Days 14 and 15 (312-336 hours after dosing).
Safety will be assessed by physical examination, vital signs (VS), 12-lead electrocardiograms, clinical laboratory tests (serum chemistry panel, hematology, coagulation, and urinalysis), use of concomitant medications, collection of adverse events, and by unscheduled assessments as needed for management of adverse events.
Subjects will be discharged from the CPC on Day 8 after completion of all 168h timepoint assessments. The Investigator will indicate whether ≥90% of the 14C radiolabel has been recovered in samples collected through 168h; if so, Day 8 will be the final study visit. If recovery of 14C in excreta is <90% by the time of discharge on Day 8, subjects will return to the site for an additional 24-hour PK confinement period on Days 14-15 (312-336h). The date of study completion for each subject will be defined as the last day that PK samples are collected. To avoid enrolling a participant with systemic 14C excess, samples of urine and/or blood (either whole blood or plasma) obtained at Screening must show no significant excess of 14C over environmental background level.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-TNP-2092 | Experimental | Drug: [14C]-TNP-2092 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Capable of understanding the written informed consent form (ICF), willingly provide valid, signed written informed consent, and willing and able to comply with the schedule, requirements, and restrictions of the study
- Males between 18 and 55 years of age (inclusive) at the time of Screening
- Body mass index (BMI) ≥18.0 kg/m2 and ≤32.0 kg/m2 at Screening; body weight ≥55.0 kg and ≤100.0 kg at Screening
- Considered to be in good health by the Investigator, as determined by medical history, physical examination, VS measurements, 12-lead ECG, and clinical laboratory test results
- Male subjects with female sexual partner(s) of reproductive potential may be enrolled if the male:
Key exclusion criteria (28 listed)
- Any contraindication to the use of rifampin/rifamycin or a fluoroquinolone
- History or presence of any condition (e.g., chronic diarrhea) or prior surgery (e.g., gastric bypass) that, in the opinion of the Investigator, poses a significant risk to subject safety and/or achievement of study objectives
- Clinically significant abnormal medical history, or any abnormal findings on physical examination, VS, ECG, or laboratory tests at Screening, Admission, or pre dose on Day 1 that, in the opinion of the Investigator, could jeopardize achieving the study objectives and/or compromise the subject's safety
- History of cancer that has not been in full remission for >5 years (except basal cell skin cancer or squamous cell skin cancer with history of curative treatment and no recurrence for >1 year prior to Screening), as judged by the Investigator
- Acute illness within 14 days prior to study drug administration on Day 1, unless mild in severity and enrollment is approved by both the Investigator and Sponsor's medical representative
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 |
|---|---|---|
| [14C]-TNP-2092Subjects will receive a single intravenous (IV) dose of 300 mg/3 µCi [14C]-TNP-2092 administered over 60 minutes (± 10 minutes). | Drug | [14C]-TNP-2092 |
Primary outcome
Mass balance of TNP-2092 and the percentages of radiolabel recovered in urine and feces
Time frame: Day 7
Percent (%) for each radiolabeled drug-related material will be determined in plasma,urine and feces.
Pharmacokinetics (PK) of TNP-2092 in plasma
Time frame: Day 7
AUC(Area under the plasma concentration) will be determined, using Linear/Log trapezoidal method, from plasma concentration data for TNP-2092
Pharmacokinetics (PK) of TNP-2092 in plasma
Time frame: Day 7
t1/2 (apparent terminal elimination half life) will be estimated for TNP-2092 from the terminal portion of its plasma concentration versus time plot
1 secondary outcome
Routes and rates of elimination of [14C] TNP 2092
Time frame: Day 7
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 19 Oct 2022.
- 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 [14C]-TNP-2092 in people with Healthy, run by TenNor Therapeutics Limited 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 12 inclusion and 28 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 19 Oct 2022. 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. 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?
Mass balance of TNP-2092 and the percentages of radiolabel recovered in urine and feces (time frame: Day 7). The study lists 3 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 19 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.