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Absorption, Metabolism, and Excretion Study of [14C]-TNP-2092

NCT05074134 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-10-19

No results posted yet for this 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).

Conditions

  • Healthy

Interventions

DRUG

[14C]-TNP-2092

Subjects will receive a single intravenous (IV) dose of 300 mg/3 µCi \[14C\]-TNP-2092 administered over 60 minutes (± 10 minutes).

Sponsors & Collaborators

  • TenNor Therapeutics Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-16
Primary Completion
2021-11-30
Completion
2022-07-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05074134 on ClinicalTrials.gov