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Completed

NCT Number: NCT04116632

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

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

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Key information

Conditions

Obese But Otherwise Healthy Participants

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences - Lenexa

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-963272

Drug

Single dose with varying frequency among groups

Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration of BMS-963272 (Cmax)

    Time frame: Day 1, Day 14

  2. Time of maximum observed concentration of BMS-963272 (Tmax)

    Time frame: Day 1, Day 14

  3. Area under the concentration-time curve in one dosing interval (AUC(TAU))

    Time frame: Day 1, Day 14

  4. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))

    Time frame: Day 14

  5. Apparent total clearance of the drug from plasma after oral administration (CLss/F)

    Time frame: Day 14

  6. Apparent volume of distribution at steady state (Vss/F)

    Time frame: Day 14

  7. Average concentration at steady state (Cavg,ss)

    Time frame: Day 14

  8. Half-life (T-HALF)

    Time frame: Day 14

  9. Accumulation index (AI)

    Time frame: Day 14

  10. Rate elimination constant (kel) of BMS-963272

    Time frame: Day 14

  11. Area under the concentration-time curve (AUC) of triglycerides (TG) and fatty acids in response to the oral lipid tolerance test (oLTT)

    Time frame: Day 7, Day 15

  12. Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT

    Time frame: Day 7, Day 15

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 55 days

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 55 days

  3. Number of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations and clinical laboratory tests

    Time frame: Up to 55 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Multiple Dose Pharmacokinetic/Pharmacodynamic and Safety and Tolerability Study of BMS-963272 in Obese But Otherwise Healthy Adults

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 4, 2019
Registry last updated
May 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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