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

Verastem, Inc.5 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

defactinibDRUG

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

Eligibility

Sex: MALEMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body mass index (BMI) 18.0 to 35.0 kg/m2 * History (Hx) regular bowel movements * Creatinine clearance \>80 mL/min Exclusion Criteria: * Hx alcohol abuse in past 2 yrs * Current smoker * Systolic blood pressure (S) or diastolic blood pressure (DBP) above upper limit of reference range (age 40-44 \>90/140; age 45-65 \>90/150)