Effect of Probenecid on Pexidartinib Pharmacokinetics

Completed · Phase 1

Conditions studied: Pharmacokinetics in Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT03138759

Run by

Daiichi Sankyo

People needed

16

Starts

2017-02-27

Expected to finish

2017-03-30

Last updated by the study team

2017-05-03

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Worldwide Clinical Trials Early Phase Services — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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