Effect of Probenecid on Pexidartinib Pharmacokinetics

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-27

Study Completion Date

2017-03-30

Brief Summary

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The primary objective of this trial is to assess the effect of probenecid on the pharmacokinetics (PK) of single-dose pexidartinib in healthy subjects.

Secondary objectives are to assess the safety and tolerability of pexidartinib alone and in combination with probenecid.

Participants will be confined to the clinic for approximately 32 days. Blood samples will be collected for PK analysis of pexidartinib and metabolites at predose and up to 312 hours (h) post dose.

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Detailed Description

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Conditions

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Pharmacokinetics in Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is an open-label, 2-treatment sequence, 2-period, crossover study with a washout between doses and treatment periods

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Pexidartinib then Probenecid

Participants receive Sequence AB: Treatment A (pexidartinib) first, then Treatment B (probenecid), with a washout period between them

Group Type EXPERIMENTAL

Pexidartinib

Intervention Type DRUG

Orally, on Day 2

Probenecid

Intervention Type DRUG

Orally, on Day 2

Probenecid then Pexidartinib

Participants receive Sequence BA: Treatment B (probenecid) first, then Treatment A (pexidartinib), with a washout period between them

Group Type EXPERIMENTAL

Pexidartinib

Intervention Type DRUG

Orally, on Day 2

Probenecid

Intervention Type DRUG

Orally, on Day 2

Interventions

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Pexidartinib

Orally, on Day 2

Intervention Type DRUG

Probenecid

Orally, on Day 2

Intervention Type DRUG

Other Intervention Names

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Treatment A Treatment B

Eligibility Criteria

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Inclusion Criteria

* Is a healthy, nonsmoking person with a body mass index of 18 kg/m2 to 30 kg/m2 (inclusive) at Screening
* Is willing to be confined at the clinic for approximately 32 days
* Is surgically sterile or a naturally postmenopausal female and not lactating, or a male who agrees to use double barrier methods of contraception and avoid donating sperm from Check-in until 90 d after the final dose of pexidartinib

Exclusion Criteria

* Has any history or condition, per protocol or in the opinion of the investigator, that might compromise the participant's safety, their ability to complete the trial, and or analysis of results

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes