Effect of BMS-986165 on the Blood Levels of Metformin
- Registration Number
- NCT04671953
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to investigate the effects of BMS-986165 on the drug levels of metformin in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Healthy, as determined by having no clinically significant deviation from normal in medical history, physical examination, electrocardiograms, vital signs, and clinical laboratory determinations
- Body mass index of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg, at screening
- Must agree to follow specific methods of contraception, if applicable
Exclusion Criteria
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 1: BMS-986165 Dose 1 + Metformin BMS-986165 - Arm 1: BMS-986165 Dose 1 + Metformin Metformin - Arm 2: BMS-986165 Dose 2 + Metformin BMS-986165 - Arm 2: BMS-986165 Dose 2 + Metformin Metformin -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) in plasma for metformin with and without BMS-986165 Up to 9 days Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T)) in plasma for metformin with and without BMS-986165 Up to 9 days Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for metformin with and without BMS-986165 Up to 9 days
- Secondary Outcome Measures
Name Time Method Incidence of adverse events (AEs) Up to 13 days Incidence of serious adverse events (SAEs) Up to 71 days Incidence of clinically significant changes in vital signs: Body temperature Up to 41 days Incidence of clinically significant changes in vital signs: Respiratory rate Up to 41 days Incidence of clinically significant changes in vital signs: Blood pressure Up to 41 days Incidence of clinically significant changes in vital signs: Heart rate Up to 41 days Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval Up to 41 days PR interval is the time from the onset of the P wave to the start of the QRS complex
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS Up to 41 days QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval Up to 41 days The QT interval is the time from the start of the Q wave to the end of the T wave
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF Up to 41 days 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
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests Up to 41 days Incidence of clinically significant changes in clinical laboratory values: Hematology tests Up to 41 days Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests Up to 41 days
Trial Locations
- Locations (1)
PRA Health Sciences - Lenexa
🇺🇸Lenexa, Kansas, United States