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

NCT02913716 | Completed Phase 1

• 1 other identifier: VS-6063-106
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (14)

• Urine amount excreted (Ae)

  Screening to 168h post-dose

• Urine fraction of the dose excreted (Fe)

  Screening to 168h post-dose

• Urine cumulative amount excreted (Cum Ae)

  Screening to 168h post-dose

• Urine cumulative fraction of the dose excreted (Cum Fe)

  Screening to 168h post-dose

• Urine renal clearance (CLr)

  Screening to 168h post-dose

• Faeces Ae

  Screening to 168h post-dose

• Faeces Fe

  Screening to 168h post-dose

• Faeces Cum Ae

  Screening to 168h post-dose

• Faeces Cum Fe

  Screening to 168h post-dose

• All excreta Ae

  Screening to 168h post-dose

• All excreta Fe

  Screening to 168h post-dose

• All excreta Cum Ae

  Screening to 168h post-dose

• All excreta Cum Fe

  Screening to 168h post-dose

• All excreta non-renal clearance (CLnr)

  Screening to 168h post-dose

Secondary Outcomes (11)

• Time at which the analyte is first quantifiable (Tlag)

  Screening to 168h post-dose

• Time from dosing at which Cmax is apparent (Tmax)

  Screening to 168h post-dose

• Maximum observed concentration (Cmax)

  Screening to 168h post-dose

• Area under the concentration vs. time curve from time zero extrapolated to last measurable concentration (AUC(0-last))

  Screening to 168h post-dose

• Area under the concentration vs. time curve from time zero to infinity (AUC (0-inf))

  Screening to 168h post-dose

Study Arms (1)

Defactinib treatment

EXPERIMENTAL

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

Drug: defactinib

Interventions

defactinib DRUG

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

Also known as: VS-6063

Defactinib treatment

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) 18.0 to 35.0 kg/m2
• History (Hx) regular bowel movements
• Creatinine clearance \>80 mL/min

You may not qualify if:

• 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)

Sponsors & Collaborators

• Verastem, Inc.: lead

MeSH Terms

Interventions

defactinib

Study Officials

• Hagop Youssoufian

  Verastem, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 26, 2016
• Study Start: August 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 30, 2017

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share