Overview
A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults
Status:
Completed
Completed
Trial end date:
2020-02-10
2020-02-10
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Bristol-Myers Squibb
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, pleasevisit www.BMSStudyConnect.com
Inclusion Criteria:
- Participants must be in good general health, in the opinion of the investigator, with
no clinically significant deviation from normal in medical history, physical
examination findings, ECGs, or laboratory results.
- Participants must have a BMI of 30 kg/m2 to 40 kg/m2 inclusive
- Women (not of childbearing potential) and men aged 18 to 60 years, inclusive
Exclusion Criteria:
- Previous participation in the current study
- Inability or unwillingness to comply with protocol-defined restrictions or
requirements regarding lifestyle, diet, concomitant medications, or other aspects of
the study
- Inability to tolerate the oLTT meal or to comply with oLTT testing conditions
- Inability to tolerate oral medication
- Inability to tolerate venipuncture and/or inadequate venous access
- Women who are breastfeeding
- Medical Conditions
- History of lactose intolerance
- Any significant (in the opinion of the investigator) acute or chronic illness
- Type 1 or 2 diabetes
- Evidence of organ dysfunction or any clinically significant deviation from normal in
physical examination, vital signs, ECG, or clinical laboratory determinations beyond
what is consistent with the target population
- Previous/Concomitant Therapy
- Previous exposure to BMS-963272
Other protocol-defined inclusion/exclusion criteria could apply