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Completed

NCT Number: NCT02913716

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

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

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Key information

Conditions

Healthy Subjects

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Defactinib

Drug

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

Other names: VS-6063

Primary outcomes

  1. Urine amount excreted (Ae)

    Time frame: Screening to 168h post-dose

  2. Urine fraction of the dose excreted (Fe)

    Time frame: Screening to 168h post-dose

  3. Urine cumulative amount excreted (Cum Ae)

    Time frame: Screening to 168h post-dose

  4. Urine cumulative fraction of the dose excreted (Cum Fe)

    Time frame: Screening to 168h post-dose

  5. Urine renal clearance (CLr)

    Time frame: Screening to 168h post-dose

  6. Faeces Ae

    Time frame: Screening to 168h post-dose

  7. Faeces Fe

    Time frame: Screening to 168h post-dose

  8. Faeces Cum Ae

    Time frame: Screening to 168h post-dose

  9. Faeces Cum Fe

    Time frame: Screening to 168h post-dose

  10. All excreta Ae

    Time frame: Screening to 168h post-dose

  11. All excreta Fe

    Time frame: Screening to 168h post-dose

  12. All excreta Cum Ae

    Time frame: Screening to 168h post-dose

  13. All excreta Cum Fe

    Time frame: Screening to 168h post-dose

  14. All excreta non-renal clearance (CLnr)

    Time frame: Screening to 168h post-dose

Secondary outcomes

  1. Time at which the analyte is first quantifiable (Tlag)

    Time frame: Screening to 168h post-dose

  2. Time from dosing at which Cmax is apparent (Tmax)

    Time frame: Screening to 168h post-dose

  3. Maximum observed concentration (Cmax)

    Time frame: Screening to 168h post-dose

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

    Time frame: Screening to 168h post-dose

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

    Time frame: Screening to 168h post-dose

  6. Percentage of AUC(0-inf) accounted for by extrapolation (AUC%extrap)

    Time frame: Screening to 168h post-dose

  7. lamdba-z

    Time frame: Screening to 168h post-dose

  8. Apparent elimination half-life (T1/2)

    Time frame: Screening to 168h post-dose

  9. Mean residence time

    Time frame: Screening to 168h post-dose

  10. Apparent clearance after oral administration (CL/F)

    Time frame: Screening to 168h post-dose

  11. Apparent volume of distribution after oral administration (Vz/F)

    Time frame: Screening to 168h post-dose

Sponsors and collaborators

Lead sponsor

Verastem, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 26, 2016
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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