A Study to Assess the Effect of Phenytoin on the Drug Levels of Afimetoran and the Effect of Afimetoran on the Drug Levels of Midazolam
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT05901714
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Afimetoran followed by phenytoin + afimetoran Afimetoran - Part 2: Midazolam followed by afimetoran + midazolam Midazolam - Part 1: Afimetoran followed by phenytoin + afimetoran Phenytoin - Part 2: Midazolam followed by afimetoran + midazolam Afimetoran -
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) Up to 53 days Parts 1 and 2
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) Up to 53 days Parts 1 and 2
Maximum observed plasma concentration (Cmax) Up to 53 days Parts 1 and 2
- Secondary Outcome Measures
Name Time Method Number of participants with clinical laboratory abnormalities Up to 66 days Parts 1 and 2
Number of participants with vital sign abnormalities Up to 66 days Parts 1 and 2
Time to attain maximum observed plasma concentration (Tmax) Up to 53 days Parts 1 and 2
Number of participants with adverse events (AEs) Up to 124 days Parts 1 and 2
Apparent total body clearance of the drug from the plasma (CLT/F) Up to 53 days Parts 1 and 2
Number of participants with physical examination abnormalities Up to 66 days Parts 1 and 2
Terminal half-life (T-Half) Up to 53 days Parts 1 and 2
Number of participants with electrocardiogram (ECG) abnormalities Up to 66 days Parts 1 and 2
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Miami, Florida, United States