Local Institution - 0001
Miami, Florida, 33136, United States
Completed
NCT Number: 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
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).
Completed
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Afimetoran
DrugSpecified dose on specified days
Other names: BMS-986256
Phenytoin
DrugSpecified dose on specified days
midazolam
DrugSpecified dose on specified days
Primary outcomes
-
Maximum observed plasma concentration (Cmax)
Time frame: 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])
Time frame: Up to 53 days
Parts 1 and 2
-
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time frame: Up to 53 days
Parts 1 and 2
Secondary outcomes
-
Time to attain maximum observed plasma concentration (Tmax)
Time frame: Up to 53 days
Parts 1 and 2
-
Terminal half-life (T-Half)
Time frame: Up to 53 days
Parts 1 and 2
-
Apparent total body clearance of the drug from the plasma (CLT/F)
Time frame: Up to 53 days
Parts 1 and 2
-
Number of participants with adverse events (AEs)
Time frame: Up to 124 days
Parts 1 and 2
-
Number of participants with clinical laboratory abnormalities
Time frame: Up to 66 days
Parts 1 and 2
-
Number of participants with physical examination abnormalities
Time frame: Up to 66 days
Parts 1 and 2
-
Number of participants with vital sign abnormalities
Time frame: Up to 66 days
Parts 1 and 2
-
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 66 days
Parts 1 and 2
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study 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)
Important dates
- Study start
- 2023
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Jun 13, 2023
- Registry last updated
- Aug 7, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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