Healthy ParticipantsPhase 1NCT07449390
Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole
A Phase 1 study testing AP31969, Carbamazepine and Itraconazole in people with Healthy Participants, run by Acesion Pharma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AP31969, Carbamazepine and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 16 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON Early Phase Services, LLC
San Antonio, Texas, 78232
About this study
Official title: 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
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
- Being tested
- AP31969, Carbamazepine, Itraconazole
- Keywords
- CYP3A4, AP31969, Carbamazepine, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP31969Drug
Oral tablets.
CarbamazepineDrug
Oral capsules.
ItraconazoleDrug
Oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: AP31969; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Maximum Observed Plasma Concentration (Cmax) of AP31969 When Administered Alone and With Carbamazepine
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Part B: AUC0-24 of AP31969 When Administered Alone and With Itraconazole
Measured: 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
Part A: Apparent Oral Clearance (CL/F) of AP31969 When Administered Alone and With Carbamazepine
Measured: 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: CL/F of AP31969 When Administered Alone and With Itraconazole
Measured: 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: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AP31969 When Administered Alone and With Carbamazepine
Measured: 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: Vz/F of AP31969 When Administered Alone and With Itraconazole
Measured: 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: 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.
Measured: AP31969 alone: Days 1 to 4; Carbamazepine alone: Days 4 to 15; Combination: Days 15 to 24
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.
Measured: AP31969 alone: Days 1 to 4; Itraconazole alone: Days 4 to 7; Combination: Days 7 to 19
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.
Measured: AP31969 alone: Days 1 to 4; Carbamazepine alone: Days 4 to 15; Combination: Days 15 to 24
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.
Measured: AP31969 alone: Days 1 to 4; Itraconazole alone: Days 4 to 7; Combination: Days 7 to 19
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.
Measured: AP31969 alone: Days 1 to 4; Carbamazepine alone: Days 4 to 15; Combination: Days 15 to 24
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.
Measured: AP31969 alone: Days 1 to 4; Itraconazole alone: Days 4 to 7; Combination: Days 7 to 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Apr 2026
- Primary completion9 May 2026
- Study completion16 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acesion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director Clinical Operations, Study director, Acesion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449390
- Sponsor's protocol ID
- AP31969-M103
- Status last verified
- May 2026
- First submitted
- 27 Feb 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07449390
- Acronym / sponsor ID
- AP31969-M103
- Conditions
- Healthy Participants
- Keywords
- CYP3A4, AP31969, Carbamazepine, Itraconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Acesion PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 9 May 2026 (actual)
- Study completion
- 16 May 2026 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A, Treatment Period 1 + Treatment Period 2: AP31969 + Carbamazepine | Experimental | Drug: AP31969, Drug: CarbamazepinePart 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. |
| Part B, Treatment Period 1 + Treatment Period 2: AP31969 + Itraconazole | Experimental | Drug: AP31969, Drug: ItraconazolePart 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP31969Oral tablets. | Drug | Part A, Treatment Period 1 + Treatment Period 2: AP31969 + Carbamazepine, Part B, Treatment Period 1 + Treatment Period 2: AP31969 + Itraconazole |
| CarbamazepineOral capsules. | Drug | Part A, Treatment Period 1 + Treatment Period 2: AP31969 + Carbamazepine |
| ItraconazoleOral tablets. | Drug | Part B, Treatment Period 1 + Treatment Period 2: AP31969 + Itraconazole |
Primary outcome
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
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
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
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
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
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
16 secondary outcomes
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
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
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
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
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
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
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
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
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
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
Part A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) of AP31969 When Administered Alone and With Carbamazepine
Time frame: AP31969 alone: Days 1 to 4; Carbamazepine alone: Days 4 to 15; Combination: Days 15 to 24
Part B: Number of Participants with AEs and SAEs of AP31969 When Administered Alone and With Itraconazole
Time frame: AP31969 alone: Days 1 to 4; Itraconazole alone: Days 4 to 7; Combination: Days 7 to 19
Part A: Number of Participants with Mild, Moderate and Severe AEs of AP31969 When Administered Alone and With Carbamazepine
Time frame: AP31969 alone: Days 1 to 4; Carbamazepine alone: Days 4 to 15; Combination: Days 15 to 24
Part B: Number of Participants with Mild, Moderate and Severe AEs of AP31969 When Administered Alone and With Itraconazole
Time frame: AP31969 alone: Days 1 to 4; Itraconazole alone: Days 4 to 7; Combination: Days 7 to 19
Part A: Number of Participants with TEAEs Related to AP31969 When Administered Alone and With Carbamazepine
Time frame: AP31969 alone: Days 1 to 4; Carbamazepine alone: Days 4 to 15; Combination: Days 15 to 24
Part B: Number of Participants with TEAEs Related to AP31969 When Administered Alone and With Itraconazole
Time frame: AP31969 alone: Days 1 to 4; Itraconazole alone: Days 4 to 7; Combination: Days 7 to 19
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Director Clinical Operations study director
Acesion Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AP31969, Carbamazepine and Itraconazole in people with Healthy Participants, run by Acesion Pharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.