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Healthy Subjects

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

Sponsored by Verastem, Inc.

About this trial

Last updated 8 years ago

Study ID

VS-6063-106

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
40 to 65 Years
Male
Male

Trial Timing

Ended 10 years ago

What is this trial about?

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

What are the participation requirements?

Yes

Inclusion Criteria

- Body mass index (BMI) 18.0 to 35.0 kg/m2

- History (Hx) regular bowel movements

- Creatinine clearance >80 mL/min

No

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)