Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole (NCT07449390) | Clinical Trial Compass
Active ā Not RecruitingPhase 1
Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole
United States28 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range18 Years ā 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Age: 18 to 55 years, inclusive, at screening.
ā. Weight: ā„50 kg, at screening.
ā. Body mass index (BMI): 18.0 to 32.0 kg/m\^2, inclusive, at screening.
ā. Sex: male or female; female participants may be of childbearing potential or of nonchildbearing potential.
ā. In good physical and mental health.
Exclusion criteria
ā. 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).
ā. Personal or first-degree relative family history of congenital long QT syndrome or sudden death.
ā. History of cardiac arrhythmias, except first degree atrial-ventricular block.
ā. QT interval corrected using fridericia's formula (QTcF)-interval \>450 ms for males and \>470 ms for females.
ā. 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).
What they're measuring
1
Part A: Maximum Observed Plasma Concentration (Cmax) of AP31969 When Administered Alone and With Carbamazepine
Timeframe: AP31969 alone: predose, and at 0.5 to 72 hours postdose on Day 1 and AP31969 in combination: predose, and at 0.5 to 72 hours postdose on Day 15; Carbamazepine alone: predose on Day 15 and morning on Day 18
2
Part B: Cmax of AP31969 When Administered Alone and With Itraconazole
Timeframe: AP31969 alone: predose, and at 0.5 to 72 hours postdose on Day 1, and AP31969 in combination: predose and at 0.5 to 144 hours postdose on Day 15; Itraconazole alone: predose on Day 7 and morning on Day 13
3
Part A: Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of AP31969 When Administered Alone and With Carbamazepine
Timeframe: AP31969 alone: predose, and at 0.5 to 72 hours postdose on Day 1 and AP31969 in combination: predose, and at 0.5 to 72 hours postdose on Day 15; Carbamazepine alone: predose on Day 15 and morning on Day 18
4
Part B: AUC0-last of AP31969 When Administered Alone and With Itraconazole
Timeframe: AP31969 alone: predose, and at 0.5 to 72 hours postdose on Day 1, and AP31969 in combination: predose and at 0.5 to 144 hours postdose on Day 15; Itraconazole alone: predose on Day 7 and morning on Day 13
5
Part A: AUC from Time 0 to Infinity (AUC0-inf) of AP31969 When Administered Alone and With Carbamazepine
Timeframe: AP31969 alone: predose, and at 0.5 to 72 hours postdose on Day 1 and AP31969 in combination: predose, and at 0.5 to 72 hours postdose on Day 15; Carbamazepine alone: predose on Day 15 and morning on Day 18
ā. 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.
ā. 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.
ā. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines \[including ecstasy\], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening or admission.
6
Part B: AUC0-inf of AP31969 When Administered Alone and With Itraconazole
Timeframe: AP31969 alone: predose, and at 0.5 to 72 hours postdose on Day 1, and AP31969 in combination: predose and at 0.5 to 144 hours postdose on Day 15; Itraconazole alone: predose on Day 7 and morning on Day 13