Healthy Participants
Conditions
Keywords
Healthy Participants, BMS-986166
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.
Interventions
DRUGBMS-986166
Specified dose on specified days
DRUGItraconazole
Specified dose on specified days
DRUGExtended Phenytoin Sodium
Specified dose on specified days
DRUGGemfibrozil
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of BMT-121795 AUC(INF) to parent AUC(INF) corrected for molecular weight (MR_AUC(INF)) | Up to Day 22 |
| Maximum observed plasma concentration (Cmax) of BMS-986166 | Up to Day 22 |
| Cmax of BMT-121795 | Up to Day 22 |
| Time of maximum observed plasma concentration (Tmax) of BMS-986166 | Up to Day 22 |
| Tmax of BMT-121795 | 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 laboratory values: Urinalysis | Up to Day 55 | — |
| 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 Adverse Events (AEs) | Up to Day 55 | — |
Countries
United States
Outcome results
None listed