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

Healthy Subjects Clinical Trial

Official title:

A Phase I, Open-label Study of the Absorption, Metabolism and Excretion of Defactinib (VS-6063-106) in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913716
• Other study ID #: VS-6063-106
• Status: Completed
• Phase: Phase 1
• First received: September 19, 2016
• Last updated: January 26, 2017
• Start date: August 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: Verastem, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• defactinib
Single oral dose of 400 mg [14C]-defactinib

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Verastem, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine amount excreted (Ae)		Screening to 168h post-dose
Primary	Urine fraction of the dose excreted (Fe)		Screening to 168h post-dose
Primary	Urine cumulative amount excreted (Cum Ae)		Screening to 168h post-dose
Primary	Urine cumulative fraction of the dose excreted (Cum Fe)		Screening to 168h post-dose
Primary	Urine renal clearance (CLr)		Screening to 168h post-dose
Primary	Faeces Ae		Screening to 168h post-dose
Primary	Faeces Fe		Screening to 168h post-dose
Primary	Faeces Cum Ae		Screening to 168h post-dose
Primary	Faeces Cum Fe		Screening to 168h post-dose
Primary	All excreta Ae		Screening to 168h post-dose
Primary	All excreta Fe		Screening to 168h post-dose
Primary	All excreta Cum Ae		Screening to 168h post-dose
Primary	All excreta Cum Fe		Screening to 168h post-dose
Primary	All excreta non-renal clearance (CLnr)		Screening to 168h post-dose
Secondary	Time at which the analyte is first quantifiable (Tlag)		Screening to 168h post-dose
Secondary	Time from dosing at which Cmax is apparent (Tmax)		Screening to 168h post-dose
Secondary	Maximum observed concentration (Cmax)		Screening to 168h post-dose
Secondary	Area under the concentration vs. time curve from time zero extrapolated to last measurable concentration (AUC(0-last))		Screening to 168h post-dose
Secondary	Area under the concentration vs. time curve from time zero to infinity (AUC (0-inf))		Screening to 168h post-dose
Secondary	Percentage of AUC(0-inf) accounted for by extrapolation (AUC%extrap)		Screening to 168h post-dose
Secondary	lamdba-z		Screening to 168h post-dose
Secondary	Apparent elimination half-life (T1/2)		Screening to 168h post-dose
Secondary	Mean residence time		Screening to 168h post-dose
Secondary	Apparent clearance after oral administration (CL/F)		Screening to 168h post-dose
Secondary	Apparent volume of distribution after oral administration (Vz/F)		Screening to 168h post-dose