A Phase I, Open-label Study of Absorption, Metabolism, and Excretion of Defactinib (VS-6063) in Healthy Male Subjects

Sponsor
Verastem, Inc.
Study ID
NCT02913716
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
MALE
Age
40 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • defactinib — DRUG
    Single oral dose of 400 mg \[14C\]-defactinib

Study Details

This study assesses the mass balance recovery, pharmacokinetics, metabolite profile and metabolite identification of defactinib.

Key Dates

Start date
Aug 31, 2015
Status verified
Sep 2016
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Defactinib treatment
    Single dose of 400 mg \[14C\]-defactinib, oral suspension

Primary Outcome Measure

Urine amount excreted (Ae) [ Time Frame: Screening to 168h post-dose ]

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