AP31969 Interaction Study in Healthy Subjects

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Acesion Pharma

Must not be taking: Prescribed medications, Herbal medications

Disqualifiers: Cardiovascular, Respiratory, Hepatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Director Clinical Operations

Principal Investigator

Acesion Pharma

Are You a Good Fit for This Trial?

Inclusion Criteria

In good physical and mental health

Body mass index (BMI): 18.0 to 32.0 kg/m^2, inclusive, at screening

I am between 18 and 55 years old.

Exclusion Criteria

I do not have any serious health conditions that could make the trial unsafe for me.

Resting supine systolic blood pressure (BP) (average of 3 readings) >160 mmHg or <80 mmHg and diastolic BP (average of 3 readings) >90 mmHg or <50 mmHg at screening or admission. If initial results do not meet these criteria, BP may be repeated if in the judgment of the Investigator there is a reason to believe the initial result is inaccurate (e.g., white coat hypertension)

I have not used any prescribed medication in the past 30 days, except birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Part A

Participants receive a single oral dose of AP31969 and multiple doses of carbamazepine

24 days

Multiple visits for dosing and monitoring

Treatment Part B

Participants receive a single oral dose of AP31969 and multiple doses of itraconazole

19 days

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carbamazepine
• Itraconazole

How Is the Trial Designed?

Group I: Part B, Treatment Period 1 + Treatment Period 2: AP31969 + Itraconazole Experimental Treatment 2 Interventions

Part B - Treatment Period 1: Participants will receive a single oral dose of AP31969 350 mg, tablet on Day 1. Part B - Treatment Period 2: Participants will receive a single oral dose of AP31969 350 mg, tablet on Day 7. In addition, participants will receive a single oral dose of itraconazole 200 mg, tablets from Day 4 to Day 6 and Days 8 to 12.

Group II: Part A, Treatment Period 1 + Treatment Period 2: AP31969 + Carbamazepine Experimental Treatment 2 Interventions

Part A - Treatment Period 1: Participants will receive a single oral dose of AP31969 350 mg, tablet on Day 1. Part A - Treatment Period 2: Participants will receive a single oral dose of AP31969 350 mg on Day 15. In addition, participants will receive carbamazepine oral capsules administered twice daily (BID) as follows: 100 mg BID on Days 4 to 6, 200 mg BID on Days 7 to 9, and 300 mg BID on Days 10 to 17.

Who Is Running the Clinical Trial?

Acesion Pharma

Lead Sponsor

Trials

2

Recruited

190+