Overview
A Study Investigating Interactions Between BMS-986322 and Rosuvastatin or Metformin in Healthy Participants
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2023-01-30
2023-01-30
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Bristol-Myers SquibbTreatments:
Metformin
Rosuvastatin Calcium
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/m^2, 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.