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NCT05074134 · ClinicalTrials.gov registry record · Phase 1
Absorption, Metabolism, and Excretion Study of [14C]-TNP-2092
A Phase 1 study, sponsored by TenNor Therapeutics Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT05074134 is a Phase 1 study that has completed, run by TenNor Therapeutics Limited. The registered enrollment target is 6 participants.
The verdict
NCT05074134, a Phase 1 study, has completed, sponsored by TenNor Therapeutics Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study 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. 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).
Interventions
- DRUG [14C]-TNP-2092
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-10-16 |
| Est. Completion | 2022-07-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05074134
The ClinicalTrials.gov registry entry for NCT05074134 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TenNor Therapeutics Limited, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which [14C]-TNP-2092 is the first listed.
NCT05074134 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05074134 about?
NCT05074134 is a clinical study titled "Absorption, Metabolism, and Excretion Study of [14C]-TNP-2092". 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 ...
What is the current status of trial NCT05074134?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-10-16. Estimated completion is 2022-07-12.
What interventions are being tested in trial NCT05074134?
The interventions under investigation include: [14C]-TNP-2092 (DRUG).
Who is sponsoring clinical trial NCT05074134?
This trial is sponsored by TenNor Therapeutics Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.
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