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CompletedNCT07449390Updated May 22, 2026

Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole

A Phase 1 interventional study of AP31969 and Carbamazepine in Healthy Participants, sponsored by Acesion Pharma. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Acesion Pharma · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Participants

Keywords

  • CYP3A4
  • AP31969
  • Carbamazepine
  • Itraconazole
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  1. 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).
  2. Personal or first-degree relative family history of congenital long QT syndrome or sudden death.
  3. History of cardiac arrhythmias, except first degree atrial-ventricular block.
  4. QT interval corrected using fridericia's formula (QTcF)-interval >450 ms for males and >470 ms for females.
  5. 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).
  6. 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.
  7. 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.
  8. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening or admission.
  9. 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.
  10. Use of alcohol within 48 hours (2 days) prior to screening or admission.
  11. History of drug addiction (including soft drugs like cannabis products) within 2 years prior to screening.
  12. Consumption of grapefruit, Seville oranges, pomelos, star fruit, or cranberries (or their juices) within 14 days prior to the first trial drug administration.
04

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

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

    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

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

    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

  • DrugAP31969

    Oral tablets.

  • DrugCarbamazepine

    Oral capsules.

  • DrugItraconazole

    Oral tablets.

05

What researchers measure

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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: tmax of AP31969 When Administered Alone and With Itraconazole

    Time frame: 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: Terminal Elimination Half-life (t1/2) of AP31969 When Administered Alone and With Carbamazepine

    Time frame: 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: t1/2 of AP31969 When Administered Alone and With Itraconazole

    Time frame: 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 24 hours (AUC0-24) of AP31969 When Administered Alone and With Carbamazepine

    Time frame: 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

  6. Part B: AUC0-24 of AP31969 When Administered Alone and With Itraconazole

    Time frame: 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; Itraconazole alone: predose on Day 7 and morning on Day 13

  7. Part A: Apparent Oral Clearance (CL/F) of AP31969 When Administered Alone and With Carbamazepine

    Time frame: 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

  8. Part B: CL/F of AP31969 When Administered Alone and With Itraconazole

    Time frame: 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

  9. Part A: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AP31969 When Administered Alone and With Carbamazepine

    Time frame: 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

  10. Part B: Vz/F of AP31969 When Administered Alone and With Itraconazole

    Time frame: 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

  11. Part A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) of AP31969 When Administered Alone and With Carbamazepine

    Any clinically significant changes in physical examination findings and abnormal objective test findings (e.g., in clinical laboratory, vital signs, ECGs) will be recorded as AEs as per investigators discretion.

    Time frame: AP31969 alone: Days 1 to 4; Carbamazepine alone: Days 4 to 15; Combination: Days 15 to 24

  12. Part B: Number of Participants with AEs and SAEs of AP31969 When Administered Alone and With Itraconazole

    Any clinically significant changes in physical examination findings and abnormal objective test findings (e.g., in clinical laboratory, vital signs, ECGs) will be recorded as AEs as per investigators discretion.

    Time frame: AP31969 alone: Days 1 to 4; Itraconazole alone: Days 4 to 7; Combination: Days 7 to 19

  13. Part A: Number of Participants with Mild, Moderate and Severe AEs of AP31969 When Administered Alone and With Carbamazepine

    The severity of AEs will be graded as follows: 1. Mild: an AE that is easily tolerated by the participant, causes minimal discomfort, does not interfere with everyday activities, and does not require intervention. 2. Moderate: an AE that is sufficiently discomforting to interfere with normal everyday activities; intervention may be needed. 3. Severe: an AE that prevents normal everyday activities; treatment or other intervention usually needed.

    Time frame: AP31969 alone: Days 1 to 4; Carbamazepine alone: Days 4 to 15; Combination: Days 15 to 24

  14. Part B: Number of Participants with Mild, Moderate and Severe AEs of AP31969 When Administered Alone and With Itraconazole

    The severity of AEs will be graded as follows: 1. Mild: an AE that is easily tolerated by the participant, causes minimal discomfort, does not interfere with everyday activities, and does not require intervention. 2. Moderate: an AE that is sufficiently discomforting to interfere with normal everyday activities; intervention may be needed. 3. Severe: an AE that prevents normal everyday activities; treatment or other intervention usually needed.

    Time frame: AP31969 alone: Days 1 to 4; Itraconazole alone: Days 4 to 7; Combination: Days 7 to 19

  15. Part A: Number of Participants with TEAEs Related to AP31969 When Administered Alone and With Carbamazepine

    The relationship between the AEs and the trial drug (AP31969, carbamazepine, or itraconazole) will be assessed and graded as none, unlikely, possibly, likely, or definitely. Adverse events graded as possibly, likely, or definitely related will be considered related to the trial drug; AEs graded as none or unlikely related will be considered not related to the trial drug.

    Time frame: AP31969 alone: Days 1 to 4; Carbamazepine alone: Days 4 to 15; Combination: Days 15 to 24

  16. Part B: Number of Participants with TEAEs Related to AP31969 When Administered Alone and With Itraconazole

    The relationship between the AEs and the trial drug (AP31969, carbamazepine, or itraconazole) will be assessed and graded as none, unlikely, possibly, likely, or definitely. Adverse events graded as possibly, likely, or definitely related will be considered related to the trial drug; AEs graded as none or unlikely related will be considered not related to the trial drug.

    Time frame: AP31969 alone: Days 1 to 4; Itraconazole alone: Days 4 to 7; Combination: Days 7 to 19

06

Study locations

1 site
  • ICON Early Phase Services, LLC
    San Antonio, Texas 78232, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07449390
Lead sponsor
Acesion Pharma
Responsible party
Sponsor
First posted
Mar 4, 2026
Start date
Apr 1, 2026
Primary completion
May 9, 2026
Completion
May 16, 2026
Last update
May 22, 2026

Study contacts

Director Clinical Operations
study director · Acesion Pharma

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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