MedDataX Logo

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

NCT ID: NCT02913716

Last Updated: 2017-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigate Absorption, Metabolism, Excretion, and Mass Balance of Pacritinib

NCT02803762

Healthy
COMPLETED PHASE1

A Study to Understand How the Study Medicine (PF-07976016) is Processed and Eliminated in Healthy Men

NCT07015918

Healthy Male Volunteers
COMPLETED PHASE1

Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961

NCT04495140

Healthy Volunteer
COMPLETED PHASE1

Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects

NCT03770039

Healthy Male Subjects
COMPLETED PHASE1

A Single Ascending Dose Study To Evaluate Safety And Pharmacokinetics Of Compound PF-06648671 In Healthy Subjects

NCT02316756

Healthy Subjects
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Defactinib treatment

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

Group Type EXPERIMENTAL

defactinib

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

defactinib

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VS-6063

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Verastem, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hagop Youssoufian

Role: STUDY_CHAIR

Verastem, Inc.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VS-6063-106

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study to Understand How the Body Processes [14C]PF-07104091 in Healthy Participants
NCT07127770 COMPLETED PHASE1
A Study To Evaluate Different Formulations Of PF-06865571 In Healthy Subjects
NCT03372044 COMPLETED PHASE1
To Calculate the Pharmacokinetics (Concentration of Compound in and Rate of Excretion From the Blood) Following a Very Low Dose of Compound Which Will Not Have Any Pharmacological Activity
NCT01165736 COMPLETED PHASE1
To Evaluate the Effect of Food on Pharmacokinetics(PK), Phase I Clinical Study of LCB01-0371
NCT02538003 COMPLETED PHASE1
Mass Balance Recovery, Metabolite Profile, and Metabolite Identification of [14C]-Paxalisib in Healthy Male Subjects
NCT05012670 COMPLETED PHASE1
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BGB-3111 in Healthy Males
NCT04163783 COMPLETED PHASE1
A Study to Understand How the Study Medicine (PF-07081532) is Processed and Eliminated in Healthy Men
NCT05652647 COMPLETED PHASE1
A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017)
NCT05511558 COMPLETED PHASE1
Mass Balance and Pharmacokinetics (PK) of [14C]-DC-806 in Healthy Male Participants
NCT06045000 COMPLETED PHASE1
A Study to Learn How the Medicine Called [14C] PF-06821497 is Taken up Into and Removed From the Body.
NCT06392230 COMPLETED PHASE1
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0941 Following Single Oral Dose Administration in Healthy Male Subjects
NCT01474668 COMPLETED PHASE1
A Study To Investigate The Elimination Of PF-06273588 From The Body Following A Single Low Dose.
NCT01408355 COMPLETED PHASE1
A Mass Balance Study of LCB01-0371 After a Single Oral LCB01-0371 Dose With a [14C]LCB01-0371-microtrace
NCT03492996 COMPLETED PHASE1
Phase I Safety and Pharmacokinetic Study of VGX-1027 in Healthy Subjects
NCT00627120 COMPLETED PHASE1
A Study to Investigate the Absorption, Metabolism and Excretion of [14C]-BGB-11417
NCT05844111 COMPLETED PHASE1
Excretion Balance, PK and Metabolism of a Single Oral Dose of [14C]PCO371
NCT04649216 COMPLETED PHASE1
An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral Administration
NCT06645704 COMPLETED PHASE1
Study to Assess the Absorption, Metabolism and Excretion of 14C-JNJ-63623872 After a Single Dose in Healthy Male Participants
NCT02448004 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of PF-06852231 in Healthy Subjects
NCT03217604 COMPLETED PHASE1
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants
NCT06281158 COMPLETED PHASE1
Single Dose Study To Study The Absorption, Metabolism And Excretion Of PF-04991532
NCT01469481 COMPLETED PHASE1
A Study To Understand Safety And Plasma Concentrations Of PF-06669571 During And Following The Oral Administration Of Single And Multiple Doses Of PF-06669571 In Healthy Volunteers Under Fasted And Fed Conditions
NCT02184429 COMPLETED PHASE1
[14C] Icosabutate -A Phase I Absorption, Metabolism and Excretion Study
NCT02373176 COMPLETED PHASE1
A Study To Investigate The Absorption, Distribution, Metabolism, And Excretion Of [14c]PF-06463922 In Healthy Male Volunteers
NCT02564562 COMPLETED PHASE1
A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions
NCT02201511 COMPLETED PHASE1