Healthy Participants
Conditions
Keywords
Drug interaction, Metformin, Pharmacodynamics, Pharmacokinetics
Brief summary
The purpose of this study is to investigate the effects of BMS-986165 on the drug levels of metformin in healthy participants.
Interventions
DRUGBMS-986165
Specified dose on specified days
DRUGMetformin
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 adverse events (AEs) | Up to 13 days | — |
| 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: Hematology tests | Up to 41 days | — |
| Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests | Up to 41 days | — |
| Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests | Up to 41 days | — |
| 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 serious adverse events (SAEs) | Up to 71 days | — |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 41 days | — |
Countries
United States
Outcome results
None listed