MedTrace Logo

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

NCT07783503 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-24

No results posted yet for this study

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.

Conditions

  • Healthy Participants

Interventions

DRUG

Pelabresib

Oral dosing

DRUG

Phenytoin

Oral dosing

DRUG

Itraconazole

Oral dosing

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-27
Primary Completion
2026-11-13
Completion
2026-11-15

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07783503 on ClinicalTrials.gov