drugset / Trial / NCT07783503
A Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants
Non-randomizedSequentialOpen-labelOther
Summary
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.
Timeline
- Start
- 2026-09-02
- Primary completion
- 2026-11-13
- Completion
- 2026-11-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itraconazole | Small molecule | — | Oral |
| Subject | Pelabresib | Small molecule | — | Oral |
| Subject | Phenytoin | Unknown | — | Oral |
Indications
No indication recorded.