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NCT07783503 · ClinicalTrials.gov record · last posted 2026-08-24

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

Name: A Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants — clinical trial record (NCT07783503)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusNot Yet Recruiting

PhasePhase 1

SponsorNovartis Pharmaceuticals

Started2026-08-27

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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.

Trial Details

NCT Number	NCT07783503
Lead Sponsor	Novartis Pharmaceuticals
Conditions	Healthy Participants
Enrollment	30 participants
Start Date	2026-08-27
Primary Completion	2026-11-13 (estimated)
Study Completion	2026-11-15 (estimated)
Updated on ClinicalTrials.gov	2026-08-24