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Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole

NCT07449390 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Healthy Participants

Interventions

DRUG

Itraconazole

Oral tablets.

DRUG

Carbamazepine

Oral capsules.

DRUG

AP31969

Oral tablets.

Sponsors & Collaborators

  • Acesion Pharma

    lead INDUSTRY

Principal Investigators

  • Director Clinical Operations · Acesion Pharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-05-09
Completion
2026-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07449390 on ClinicalTrials.gov