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NOT YET RECRUITING
NCT07449390
PHASE1

Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole

Sponsor: Acesion Pharma

View on ClinicalTrials.gov

Summary

The primary objective of the trial is to assess the effect of multiple doses of the cytochrome P450 (CYP3A4) enzyme inducer carbamazepine (Part A) or the CYP3A4 inhibitor itraconazole (Part B) on the single-dose pharmacokinetics (PK) of AP31969 in healthy participants.

Official title: Open-label, 2-Part, Fixed-sequence, Crossover Trial Design to Determine the Effect of a Strong CYP3A4 Inducer (Carbamazepine) And a Strong CYP3A4 Inhibitor (Itraconazole) on the Pharmacokinetics of a Single Oral Dose of AP31969 in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-04-22

Completion Date

2026-05-16

Last Updated

2026-03-20

Healthy Volunteers

Yes

Interventions

DRUG

AP31969

Oral tablets.

DRUG

Carbamazepine

Oral capsules.

DRUG

Itraconazole

Oral tablets.