NCT06834295

A Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]Vapendavir

An Open-label, Single-dose Study To Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]Vapendavir in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Altesa Biosciences, Inc. · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to assess how the body processes, breaks down and removes a new test medicine (vapendavir) from the body in healthy male participants.The main question it aims to answer is how the body handles the test medicine. In order to do that, the test medicine will be radiolabeled to track the test medicine in the body. Healthy male participants who meet entry criteria will be admitted to the clinic for a duration of approximately 9 days (Day -1 to Day 8). Participants will be admitted in the evening on the day before dosing (Day -1). Participants will take a single oral dose of radiolabeled vapendavir on Day 1 and have samples collected and safety tests completed during various times throughout their stay in the the clinic. The safety tests will provide additional information on the safety and tolerability of the test medicine.

Conditions

• Healthy Males

Interventions

Type	Name	Description
DRUG	Vapendavir	Single oral dose of \[14C\]vapendavir

Timeline

• Start date: 2025-03-12
• Primary completion: 2025-03-23
• Completion: 2025-03-23
• First posted: 2025-02-19
• Last updated: 2025-05-28

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study