Mass Balance Clinical Trial With TEV-56286
- Study Title
- 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
- Teva Identifier
- TV56286-MB-10193
- ClinicalTrials.gov Identifier
- NCT06627231
- Study Status
- Completed
- Trial Condition(s)
- Healthy Participants
- Interventions
- Drug: TEV-56286; [14C]-TEV-56286
- EU CT Number
- 2024-515556-20-00
- Study 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.
Key Participation Requirements
- Gender
- Male
- Age group
- Adult
- Age Range
- 18 Years to 65 Years
- Trial Duration
- October 08, 2024 - November 29, 2024
- Phase
- Phase 1
