NCT03138759

Effect of Probenecid on Pexidartinib Pharmacokinetics

An Open-label, Randomized, 2-treatment, 2-period, Crossover Study to Evaluate the Effect of Probenecid on the Pharmacokinetics of Pexidartinib in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pharmacokinetics in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Pexidartinib	Orally, on Day 2
DRUG	Probenecid	Orally, on Day 2

Timeline

• Start date: 2017-02-27
• Primary completion: 2017-03-30
• Completion: 2017-03-30
• First posted: 2017-05-03
• Last updated: 2017-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study