Status:
COMPLETED
A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Obese But Otherwise Healthy Participants
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04116632
Start Date
September 30 2019
End Date
February 10 2020
Last Update
May 15 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PRA Health Sciences - Lenexa
Lenexa, Kansas, United States, 66219