Healthy Participants Clinical Trial
Official title:
An Open-label, Single-sequence, Drug-drug Interaction Study in Healthy Participants to Assess the Effect of Phenytoin on the Pharmacokinetics of a Single Oral Dose of Afimetoran (BMS-986256) (Part 1) and the Effect of Steady-state Afimetoran on the Pharmacokinetics of Midazolam (Part 2)
This study will consist of 2 parts. The study will evaluate whether administration of phenytoin impacts the single-dose drug levels of afimetoran and BMT-271199 (Part 1) and will evaluate whether multiple administrations of afimetoran impact the drug levels of midazolam and 1-hydroxymidazolam (Part 2).
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | October 17, 2023 |
| Est. primary completion date | October 17, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | Inclusion Criteria: - Body mass index (BMI) of 19.0 kilograms per meter squared (kg/m^2) to 32.0 kg/m2, inclusive, and body weight = 55 kg, at screening. Exclusion Criteria: - Any significant acute or chronic medical illness or any other condition listed as a contraindication in the phenytoin (Part 1) or midazolam (Part 2) package inserts. - History of seizure (including simple febrile seizure), epilepsy, severe head injury (including concussion), multiple sclerosis, or other known neurological condition which the investigator considers to be clinically significant. - Current or recent (within 3 months of study intervention administration) GI disease that could impact upon the absorption of study intervention. Other protocol-defined inclusion/exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Syneos Health Clinical Research Services, Llc | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Parts 1 and 2 | Up to 53 days | |
| Primary | Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) | Parts 1 and 2 | Up to 53 days | |
| Primary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Parts 1 and 2 | Up to 53 days | |
| Secondary | Time to attain maximum observed plasma concentration (Tmax) | Parts 1 and 2 | Up to 53 days | |
| Secondary | Terminal half-life (T-Half) | Parts 1 and 2 | Up to 53 days | |
| Secondary | Apparent total body clearance of the drug from the plasma (CLT/F) | Parts 1 and 2 | Up to 53 days | |
| Secondary | Number of participants with adverse events (AEs) | Parts 1 and 2 | Up to 124 days | |
| Secondary | Number of participants with clinical laboratory abnormalities | Parts 1 and 2 | Up to 66 days | |
| Secondary | Number of participants with physical examination abnormalities | Parts 1 and 2 | Up to 66 days | |
| Secondary | Number of participants with vital sign abnormalities | Parts 1 and 2 | Up to 66 days | |
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Parts 1 and 2 | Up to 66 days |
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