Healthy volunteers help test how common meds change AP31969 levels
NCT ID NCT07449390
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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28 people
The number who actually took part.
- Started
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Apr 2026
- Finished
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May 2026
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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ICON Early Phase Services, LLC
San Antonio, Texas, 78232, United States
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