Clinical trial NCT05901714: 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: BMS-986256
Afimetoran
Midazolam
CYP3A4
Phenytoin
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-06-13
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 53 days
measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
timeFrame: Up to 53 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
timeFrame: Up to 53 days
Secondary outcomes:
measure: Time to attain maximum observed plasma concentration (Tmax)
timeFrame: Up to 53 days
measure: Terminal half-life (T-Half)
timeFrame: Up to 53 days
measure: Apparent total body clearance of the drug from the plasma (CLT/F)
timeFrame: Up to 53 days
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 124 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 66 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 66 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 66 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 66 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Local Institution - 0001
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: