A Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants
brief 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.
detailed description
This is a 2-part, open-label, drug-drug interaction (DDI) study to assess the effect of phenytoin (a strong CYP3A4 inducer) and itraconazole (a strong CYP3A4 inhibitor) on the pharmacokinetics of pelabresib in healthy participants.
The study includes two parts, each with two treatment periods. In Part 1, participants will be administered pelabresib in Treatment Period 1 and pelabresib and phenytoin in Treatment Period 2.
In Part 2, participants will be administered pelabresib in Treatment Period 1 and pelabresib and itraconazole in Treatment Period 2.
official title
A Phase 1, Two-part, Open-label, Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants