Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole

NCT07449390 | Completed Phase 1 FDA Drug

• 1 other identifier: AP31969-M103
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CYP3A4; AP31969; Carbamazepine; Itraconazole

Outcome Measures

Primary Outcomes (6)

• Part A: Maximum Observed Plasma Concentration (Cmax) of AP31969 When Administered Alone and With Carbamazepine

  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

• Part B: Cmax of AP31969 When Administered Alone and With Itraconazole

  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

• 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

  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

• Part B: AUC0-last of AP31969 When Administered Alone and With Itraconazole

  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

• Part A: AUC from Time 0 to Infinity (AUC0-inf) of AP31969 When Administered Alone and With Carbamazepine

  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

• Part B: AUC0-inf of AP31969 When Administered Alone and With Itraconazole

  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

Secondary Outcomes (16)

• Part A: Time to Cmax (tmax) of AP31969 When Administered Alone and With Carbamazepine

  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

• Part B: tmax of AP31969 When Administered Alone and With Itraconazole

  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

• Part A: Terminal Elimination Half-life (t1/2) of AP31969 When Administered Alone and With Carbamazepine

  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

• Part B: t1/2 of AP31969 When Administered Alone and With Itraconazole

  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

• Part A: AUC from Time 0 to 24 hours (AUC0-24) of AP31969 When Administered Alone and With Carbamazepine

  AP31969 alone: predose, and at 0.5 to 24 hours postdose on Day 1 and AP31969 in combination: predose, and at 0.5 to 24 hours postdose on Day 15; Carbamazepine alone: predose on Day 15 and morning on Day 18

Study Arms (2)

Part A, Treatment Period 1 + Treatment Period 2: AP31969 + Carbamazepine

EXPERIMENTAL

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.

Drug: AP31969; Drug: Carbamazepine

Part B, Treatment Period 1 + Treatment Period 2: AP31969 + Itraconazole

EXPERIMENTAL

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.

Drug: AP31969; Drug: Itraconazole

Interventions

AP31969 DRUG

Oral tablets.

Part A, Treatment Period 1 + Treatment Period 2: AP31969 + Carbamazepine; Part B, Treatment Period 1 + Treatment Period 2: AP31969 + Itraconazole

Carbamazepine DRUG

Oral capsules.

Part A, Treatment Period 1 + Treatment Period 2: AP31969 + Carbamazepine

Itraconazole DRUG

Oral tablets.

Part B, Treatment Period 1 + Treatment Period 2: AP31969 + Itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acesion Pharma: lead

Study Sites (1)

ICON Early Phase Services, LLC

San Antonio, Texas, 78232, United States

Location

MeSH Terms

Interventions

Carbamazepine; Itraconazole

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperazines

Study Officials

• Director Clinical Operations

  Acesion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: April 1, 2026
• Primary Completion: May 9, 2026
• Study Completion: May 16, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)