Clinical trial NCT04671953: Effect of BMS-986165 on the Blood Levels of Metformin
Official title: An Open-label, Two-arm Crossover Study to Investigate the Effect of BMS-986165 on the Pharmacokinetics of Metformin in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Drug interaction
Metformin
Pharmacodynamics
Pharmacokinetics
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of BMS-986165 on the drug levels of metformin in healthy participants.


Eligibility 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/exclusion criteria apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) in plasma for metformin with and without BMS-986165
timeFrame: Up to 9 days
measure: 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
timeFrame: Up to 9 days
measure: 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
timeFrame: Up to 9 days
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 13 days
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 71 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in clinical laboratory values: Hematology tests
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
timeFrame: Up to 41 days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA Health Sciences - Lenexa
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: