ClinicaliQ Trial Snapshot
- A Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants — Recruiting • Phase I • NCT07783503.
- Phenytoin and itraconazole significantly alter pelabresib blood levels; phenytoin reduces levels while itraconazole increases them in healthy volunteers.
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What This Trial Is Studying
The purpose of this study is to assess the effect of multiple doses of phenytoin, a strong cytochrome P450 (CYP)3A4 inducer, and itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetic (PK) profile of DAK539 (hereafter referred to as pelabresib) after a single dose in healthy participants. In addition, the safety and tolerability of a single dose of pelabresib with and without the co-administration of itraconazole or phenytoin will be evaluated. Conditions: Healthy Participants Interventions: Pelabresib, Phenytoin, Itraconazole Lead Sponsor: Novartis Pharmaceuticals Planned Enrollment: 30 participants