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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Obese But Otherwise Healthy Participants

Treatments: Drug: Placebo; Drug: BMS-963272

Study type: Interventional

Funder types: Industry

Identifiers

NCT04116632

MB006-017

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 3 patient groups

BMS-963272 or Placebo once daily (QD)

Experimental group

Treatment:

Drug: BMS-963272

Drug: Placebo

BMS-963272 or Placebo every 12 hours (Q12H)

Experimental group

Treatment:

Drug: BMS-963272

Drug: Placebo

BMS-963272 or Placebo every 8 hours (Q8H)

Experimental group

Treatment:

Drug: BMS-963272

Drug: Placebo