MedTrace Logo

Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled BVD-523 in Volunteers

NCT02994732 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-06-17

Study results available
· View outcomes & findings →

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.

Conditions

  • Healthy

Interventions

DRUG

[14C]-BVD-523

\[14C\]-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.

Sponsors & Collaborators

  • BioMed Valley Discoveries, Inc

    lead INDUSTRY

Principal Investigators

  • Irene Mirkin, MD · Covance

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-02-28
Completion
2017-05-15

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02994732 on ClinicalTrials.gov