NCT06627231

Mass Balance Clinical Trial With TEV-56286

A Phase 1 Open-Label Mass Balance Clinical Trial to Investigate the Absorption, Metabolism, and Excretion of Single Oral Administration of [14C]-TEV-56286 Following Multiple Oral Administrations of Nonlabeled TEV-56286 to Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Mass balance clinical trial with TEV-56286

Detailed description

Primary objectives: * To investigate the mass balance and excretion of TEV-56286 following a single oral dose of \[14C\]-TEV-56286 * To assess the pharmacokinetics following a single oral dose of \[14C\]-TEV-56286 Secondary objective: \- To evaluate the safety and tolerability of TEV-56286 following once daily multiple oral dose administration The total duration of the clinical trial for each participant is expected to be approximately 59 days.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	TEV-56286	Oral capsule
DRUG	[14C]-TEV-56286	Oral capsule

Timeline

• Start date: 2024-10-08
• Primary completion: 2024-11-29
• Completion: 2024-11-29
• First posted: 2024-10-04
• Last updated: 2025-01-29

Locations

1 site across 1 country: Netherlands