RecruitingPhase 1NCT07449390

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

Sponsor

Acesion Pharma

Enrollment

28 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Participants

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria5

Age: 18 to 55 years, inclusive, at screening.
Weight: ≥50 kg, at screening.
Body mass index (BMI): 18.0 to 32.0 kg/m\^2, inclusive, at screening.
Sex: male or female; female participants may be of childbearing potential or of nonchildbearing potential.
In good physical and mental health.

Exclusion Criteria12

History and/or presence of any illness or condition that, in the opinion of the Investigator, might confound the results of the trial or pose an additional risk when administering the trial drugs to the participant (with particular focus on cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, cerebrovascular, and neurological diseases including history of syncope and/or convulsions).
Personal or first-degree relative family history of congenital long QT syndrome or sudden death.
History of cardiac arrhythmias, except first degree atrial-ventricular block.
QT interval corrected using fridericia's formula (QTcF)-interval >450 ms for males and >470 ms for females.
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).
Use of any prescribed medication within 30 days prior to admission, based on Investigator's judgment. An exception is made for hormonal contraceptives, which may be used throughout the trial.
Use of any over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) within 14 days prior to admission, based on Investigator's judgment. An exception is made for acetaminophen/paracetamol, which is allowed up to 2 g/day.
Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines \[including ecstasy\], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening or admission.
Alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink=12 oz beer, 5 oz wine, and 1.5 oz spirits) within 12 months prior to screening.
Use of alcohol within 48 hours (2 days) prior to screening or admission.
History of drug addiction (including soft drugs like cannabis products) within 2 years prior to screening.
Consumption of grapefruit, Seville oranges, pomelos, star fruit, or cranberries (or their juices) within 14 days prior to the first trial drug administration.