Trials / Not Yet Recruiting
Not Yet RecruitingNCT07449390
Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole
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
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- Sponsor
- Acesion Pharma · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AP31969 | Oral tablets. |
| DRUG | Carbamazepine | Oral capsules. |
| DRUG | Itraconazole | Oral tablets. |
Timeline
- Start date
- 2026-04-22
- Primary completion
- 2026-05-16
- Completion
- 2026-05-16
- First posted
- 2026-03-04
- Last updated
- 2026-03-20
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07449390. Inclusion in this directory is not an endorsement.