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.

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Participation criteria and map of study locations

CTIS


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

Study Type

Interventional