Effect of BMS-986165 on the Blood Levels of Metformin
An Open-label, Two-arm Crossover Study to Investigate the Effect of BMS-986165 on the Pharmacokinetics of Metformin in Healthy Volunteers
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of this study is to investigate the effects of BMS-986165 on the drug levels of metformin in healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedStudy Start
First participant enrolled
December 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedNovember 11, 2021
November 1, 2021
3 months
December 15, 2020
November 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (13)
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
- +8 more secondary outcomes
Study Arms (2)
Arm 1: BMS-986165 Dose 1 + Metformin
EXPERIMENTALArm 2: BMS-986165 Dose 2 + Metformin
EXPERIMENTALInterventions
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRA Health Sciences - Lenexa
Lenexa, Kansas, 66219, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2020
First Posted
December 17, 2020
Study Start
December 18, 2020
Primary Completion
March 3, 2021
Study Completion
March 30, 2021
Last Updated
November 11, 2021
Record last verified: 2021-11