At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 6 enrolled

Drug / intervention

[14C]-BVD-523drug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02994732

NCT02994732Phase 1Completed

Compare CT.gov

A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BVD-523 Following Single Oral Dose Administration in Healthy Male Subjects

BioMed Valley Discoveries, Inc·interventional·Posted Dec 16, 2016·Updated Jun 17, 2019

In Brief

A Phase 1 clinical trial evaluating [14C]-BVD-523 for Healthy. Completed, enrolled 6 participants.

Detailed Summary

The primary objective of this study is to characterize the metabolic disposition, pharmacokinetics (PK), and routes of elimination of \[14C\]-labeled BVD-523 after administration of a single, oral dose to healthy male subjects. The secondary objective of this study is to evaluate the safety and tolerability of a single oral dose of \[14C\]-labeled BVD-523 in healthy male subjects.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy

Countries--

Collaborators--

Timeline

Phase 1CompletedFinished

2017201820192020202120222023202420252026

First PostedDec 2016

Enrollment StartJan 2017

Primary CompletionFeb 2017

Study CompletionMay 2017

TodayJul 2026

First PostedDec 16, 2016

Enrollment StartJan 1, 2017

Primary CompletionFeb 1, 2017

Study CompletionMay 15, 2017

TodayJul 2, 2026

Enrollment to primary: 1 monthPosted 9.5 years ago

Interventions

[14C]-BVD-523drug

\[14C\]-BVD-523 administered as a 600-mg (approximately 200 µCi) oral dose to 6 healthy male subjects following a 2-hour fast from food (not including water) that follows breakfast.