At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Single Sequence, Crossover Drug-drug Interaction Study Assessing the Effect of Pexidartinib on the Pharmacokinetics of CYP3A4 and CYP2C9 Substrates in Patients
In Brief
A Phase 1 clinical trial evaluating Tolbutamide, Midazolam, and 1 other intervention for Drug Interaction Potential. Completed, enrolled 32 participants across 11 sites in 4 countries.
Detailed Summary
This study has two parts. Part 1 will evaluate how pexidartinib affects the way the body processes CYP3A4 and CYP2C9 substrates using midazolam and tolbutamide, respectively, as probe agents. Part 2 will test the efficacy and safety of pexidartinib treatment in various tumor types. In Part 2, the same participants will continue to receive pexidartinib twice daily. Participants will be allowed to continue using pexidartinib as long as the participant derives benefit.
Study Details
Timeline
Interventions
Commercially available tolbutamide
Commercially available midazolam
Pexidartinib is formulated as opaque, white, 200-mg capsules