A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: Obese But Otherwise Healthy Participants

In brief

This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.

Key facts

Study ID

NCT04116632

Run by

Bristol-Myers Squibb

People needed

36

Starts

2019-09-30

Expected to finish

2020-02-10

Last updated by the study team

2020-05-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PRA Health Sciences - Lenexa — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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