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

Verastem

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: defactinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02913716

VS-6063-106

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: Male

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Defactinib treatment

Experimental group

Description:

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

Treatment:

Drug: defactinib