A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults
NCT ID: NCT04116632
Last Updated: 2020-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2019-09-30
2020-02-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BMS-963272 or Placebo once daily (QD)
BMS-963272
Single dose with varying frequency among groups
Placebo
Specified dose on specified days
BMS-963272 or Placebo every 12 hours (Q12H)
BMS-963272
Single dose with varying frequency among groups
Placebo
Specified dose on specified days
BMS-963272 or Placebo every 8 hours (Q8H)
BMS-963272
Single dose with varying frequency among groups
Placebo
Specified dose on specified days
Interventions
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BMS-963272
Single dose with varying frequency among groups
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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PRA Health Sciences - Lenexa
Lenexa, Kansas, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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MB006-017
Identifier Type: -
Identifier Source: org_study_id
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