A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT04956627
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the effect of itraconazole, phenytoin and gemfibrozil on the drug levels of BMS-986166 and its active metabolite BMT-121795. Participants will be randomly assigned to one of four groups and will remain in the study clinic for the duration of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Body weight of at least 55 kg.
- Body mass index (BMI) of 19.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/(height [m])².
- Healthy female subjects of non-childbearing potential, or male subjects, as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations.
Exclusion Criteria
- Any significant acute or chronic medical illness or any other condition listed as a contraindication in the itraconazole, phenytoin, or gemfibrozil package inserts.
- History of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant 12-lead ECG abnormalities, or any congenital heart disease.
- History of stroke or transient ischemic attacks.
- History of asthma or chronic obstructive pulmonary disease diagnosed or treated within the past 5 years.
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-986166 BMS-986166 - BMS-986166 + Itraconazole BMS-986166 - BMS-986166 + Phenytoin BMS-986166 - BMS-986166 + Gemfibrozil BMS-986166 - BMS-986166 + Gemfibrozil Gemfibrozil - BMS-986166 + Phenytoin Extended Phenytoin Sodium - BMS-986166 + Itraconazole Itraconazole -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) of BMS-986166 Up to Day 22 Tmax of BMT-121795 Up to Day 22 Time of maximum observed plasma concentration (Tmax) of BMS-986166 Up to Day 22 Cmax of BMT-121795 Up to Day 22 Ratio of BMT-121795 Cmax to parent Cmax corrected for molecular weight (MR_Cmax) Up to Day 22 Ratio of BMT-121795 AUC(0-T) to parent AUC(0-T) corrected for molecular weight (MR_AUC(0-T)) Up to Day 22 Ratio of BMT-121795 AUC(INF) to parent AUC(INF) corrected for molecular weight (MR_AUC(INF)) Up to Day 22 Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986166 Up to Day 22 AUC(0-T) of BMT-121795 Up to Day 22 Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))of BMS-986166 Up to Day 22 AUC(INF) of BMT-121795 Up to Day 22 Terminal plasma half-life (T-HALF) of BMS-986166 Up to Day 22 T-HALF of BMT-121795 Up to Day 22 Apparent total body clearance (CL/F) of BMS-986166 Up to Day 22 Apparent volume of distribution (Vz/F) of BMS-986166 Up to Day 22
- Secondary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) Up to Day 55 Number of participants with Serious Adverse Events (SAEs) Up to Day 55 Number of participants with physical examination abnormalities Up to Day 55 Number of participants with clinically significant changes in vital signs: Body temperature Up to Day 55 Number of participants with clinically significant changes in vital signs: Respiratory rate Up to Day 55 Number of participants with clinically significant changes in vital signs: Blood pressure Up to Day 55 Number of participants with clinically significant changes in vital signs: Heart rate Up to Day 55 Number of participants with clinically significant changes in ECG parameters: PR interval Up to Day 55 PR interval is the time from the onset of the P wave to the start of the QRS complex
Number of participants with clinically significant changes in ECG parameters: QRS Up to Day 55 QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Number of participants with clinically significant changes in ECG parameters: QT interval Up to Day 55 The QT interval is the time from the start of the Q wave to the end of the T wave
Number of participants with clinically significant changes in ECG parameters: QTcF Up to Day 55 QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Number of participants with clinically significant changes in laboratory values: Hematology tests Up to Day 55 Number of participants with clinically significant changes in laboratory values: Chemistry tests Up to Day 55 Number of participants with clinically significant changes in laboratory values: Urinalysis Up to Day 55
Trial Locations
- Locations (1)
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States