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NOT YET RECRUITING
NCT07783503
PHASE1

A Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-08-27

Completion Date

2026-11-15

Last Updated

2026-08-24

Healthy Volunteers

Yes

Interventions

DRUG

Pelabresib

Oral dosing

DRUG

Phenytoin

Oral dosing

DRUG

Itraconazole

Oral dosing