Absorption, Metabolism, and Excretion Study of [14C]-TNP-2092
Public ClinicalTrials.gov record NCT05074134. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05074134
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 6 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 15, 2021
- Primary completion
- Nov 29, 2021
- Completion
- Jul 11, 2022
- Last update posted
- Oct 18, 2022
2021 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pharmaron Clinical Pharmacology Center | Baltimore | Maryland | 21201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05074134, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 18, 2022 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05074134 live on ClinicalTrials.gov.