A Study Investigating Interactions Between BMS-986322 and Rosuvastatin or Metformin in Healthy Participants
Study Details
Study Description
Brief Summary
The aim of this study is to assess the effect of coadministration of multiple oral doses of BMS-986322 with rosuvastatin or metformin in healthy participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1: Rosuvastatin + BMS-986322
|
Drug: BMS-986322
Specified dose on specified days
Drug: Rosuvastatin
Specified dose on specified days
|
| Experimental: Part 2: Metformin + BMS-986322 + Glucose
|
Drug: BMS-986322
Specified dose on specified days
Drug: Metformin
Specified dose on specified days
Dietary Supplement: Glucose
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- Maximum observed plasma concentration (Cmax) [Up to 21 days]
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) [Up to 21 days]
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) [Up to 21 days]
Secondary Outcome Measures
- Time of maximum observed plasma concentration (Tmax) [Up to 21 days]
- Apparent terminal phase half-life (T-HALF) [Up to 21 days]
- Apparent total body clearance (CLT/F) [Up to 21 days]
- Number of participants with adverse events (AEs) [Up to 51 days]
- Number of participants with vital sign abnormalities [Up to 51 days]
- Number of participants with electrocardiogram (ECG) abnormalities [Up to 51 days]
- Number of participants with physical examination abnormalities [Up to 51 days]
- Number of participants with clinical laboratory abnormalities [Up to 51 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
In the opinion of the investigator, a healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
-
Body mass index (BMI) of 18.0 kilogram (kg)/meter(m)2 to 30.0 kg/m2, inclusive, and body weight ≥ 50 kg for males and ≥ 45 kg for females, at screening.
-
A female participant is eligible to participate if she is a woman not of childbearing potential.
-
Female participants must refrain from donating oocytes during the intervention period and for at least 5 half-lives (5 days) after the last dose of study intervention.
Exclusion Criteria:
-
Any significant acute or chronic medical illness.
-
Any major surgery, including any gastrointestinal (GI) surgery, with the exception of appendectomy, within 90 days of study intervention administration.
-
History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women or 14 units for men of alcohol per week (1 unit = 340 mililitre [mL] of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
Other protocol-defined inclusion/exclusion criteria apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.- IM032-039