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Healthy volunteers help test how common meds change AP31969 levels

NCT ID NCT07449390

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how two common drugs—carbamazepine (a strong inducer) and itraconazole (a strong inhibitor)—affect the levels of a single dose of AP31969 in the blood of 28 healthy adults. The goal was to understand how these interactions might change the drug's breakdown, which helps guide safe dosing in future studies. Participants took AP31969 alone and then with each other drug to compare the effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

28 people

The number who actually took part.

Started

Apr 2026

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • ICON Early Phase Services, LLC

    San Antonio, Texas, 78232, United States

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