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

NCT05901714 — Phase 1, Completed, 65 participants, Bristol-Myers Squibb

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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)

Registry	NCT05901714
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, sequential, masking: none, treatment
Enrollment	65 (Actual)
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Healthy Participants
Interventions	Afimetoran, Phenytoin, Midazolam (Drug)
Dates	start 2023-06-14, primary completion 2024-04-11, completion 2024-04-11, first posted 2023-06-13, last updated 2024-08-07
Locations	1 site in United States

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
Part 1: Afimetoran followed by phenytoin + afimetoran	Experimental	Drug: Afimetoran; Drug: Phenytoin
Part 2: Midazolam followed by afimetoran + midazolam	Experimental	Drug: Afimetoran; Drug: Midazolam

Afimetoran (Drug), also known as BMS-986256: Specified dose on specified days
Phenytoin (Drug): Specified dose on specified days
Midazolam (Drug): Specified dose on specified days

+Outcome measures

Primary outcomes

Maximum observed plasma concentration (Cmax) [Up to 53 days]: Parts 1 and 2
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

Secondary outcomes

Time to attain maximum observed plasma concentration (Tmax) [Up to 53 days]: Parts 1 and 2
Terminal half-life (T-Half) [Up to 53 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 adverse events (AEs) [Up to 124 days]: Parts 1 and 2
Number of participants with clinical laboratory abnormalities [Up to 66 days]: Parts 1 and 2
Number of participants with physical examination abnormalities [Up to 66 days]: Parts 1 and 2
Number of participants with vital sign abnormalities [Up to 66 days]: Parts 1 and 2
Number of participants with electrocardiogram (ECG) abnormalities [Up to 66 days]: Parts 1 and 2

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Local Institution - 0001	Miami, Florida	United States

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb