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Healthy SubjectsPhase 1NCT02913716

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

A Phase 1 study testing defactinib in people with Healthy Subjects, run by Verastem, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 40 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
defactinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
No sites listed yet
Study dates
Aug 2015to Sep 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

About this study

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

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

Being tested
defactinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • defactinibDrug

    Also called VS-6063

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

Study groups in NCT02913716
Study groupRoleWhat they receive
Defactinib treatmentExperimentalSingle dose of 400 mg [14C]-defactinib, oral suspension
Receives: Drug: defactinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urine amount excreted (Ae)

    Measured: Screening to 168h post-dose

  2. Urine fraction of the dose excreted (Fe)

    Measured: Screening to 168h post-dose

  3. Urine cumulative amount excreted (Cum Ae)

    Measured: Screening to 168h post-dose

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

    Measured: Screening to 168h post-dose

  5. Urine renal clearance (CLr)

    Measured: Screening to 168h post-dose

  6. Faeces Ae

    Measured: Screening to 168h post-dose

  7. Faeces Fe

    Measured: Screening to 168h post-dose

  8. Faeces Cum Ae

    Measured: Screening to 168h post-dose

  9. Faeces Cum Fe

    Measured: Screening to 168h post-dose

  10. All excreta Ae

    Measured: Screening to 168h post-dose

  11. All excreta Fe

    Measured: Screening to 168h post-dose

  12. All excreta Cum Ae

    Measured: Screening to 168h post-dose

  13. All excreta Cum Fe

    Measured: Screening to 168h post-dose

  14. All excreta non-renal clearance (CLnr)

    Measured: Screening to 168h post-dose

Secondary outcomes (11)

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

    Measured: Screening to 168h post-dose

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

    Measured: Screening to 168h post-dose

  3. Maximum observed concentration (Cmax)

    Measured: Screening to 168h post-dose

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

    Measured: Screening to 168h post-dose

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

    Measured: Screening to 168h post-dose

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

    Measured: Screening to 168h post-dose

  7. lamdba-z

    Measured: Screening to 168h post-dose

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

    Measured: Screening to 168h post-dose

  9. Mean residence time

    Measured: Screening to 168h post-dose

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

    Measured: Screening to 168h post-dose

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

    Measured: Screening to 168h post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2016 (estimated)
  2. Study startAug 2015
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02913716
Sponsor's protocol ID
VS-6063-106
Status last verified
Sep 2016
First submitted
19 Sep 2016
Last updated
30 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing defactinib in people with Healthy Subjects, run by Verastem, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urine amount excreted (Ae) (time frame: Screening to 168h post-dose). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02913716.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.

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