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

A Multiple Dose Pharmacokinetic/Pharmacodynamic and Safety and Tolerability Study 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.

Study Overview

• Status: Completed
• Conditions: Obese But Otherwise Healthy Participants
• Intervention / Treatment: Drug: Placebo; Drug: BMS-963272

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • PRA Health Sciences - Lenexa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BMS-963272 or Placebo once daily (QD)	Drug: Placebo; Specified dose on specified days; Drug: BMS-963272; Single dose with varying frequency among groups
EXPERIMENTAL: BMS-963272 or Placebo every 12 hours (Q12H)	Drug: Placebo; Specified dose on specified days; Drug: BMS-963272; Single dose with varying frequency among groups
EXPERIMENTAL: BMS-963272 or Placebo every 8 hours (Q8H)	Drug: Placebo; Specified dose on specified days; Drug: BMS-963272; Single dose with varying frequency among groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration of BMS-963272 (Cmax)	Day 1, Day 14
Time of maximum observed concentration of BMS-963272 (Tmax)	Day 1, Day 14
Area under the concentration-time curve in one dosing interval (AUC(TAU))	Day 1, Day 14
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))	Day 14
Apparent total clearance of the drug from plasma after oral administration (CLss/F)	Day 14
Apparent volume of distribution at steady state (Vss/F)	Day 14
Average concentration at steady state (Cavg,ss)	Day 14
Half-life (T-HALF)	Day 14
Accumulation index (AI)	Day 14
Rate elimination constant (kel) of BMS-963272	Day 14
Area under the concentration-time curve (AUC) of triglycerides (TG) and fatty acids in response to the oral lipid tolerance test (oLTT)	Day 7, Day 15
Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT	Day 7, Day 15

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events (AEs)	Up to 55 days
Incidence of Serious Adverse Events (SAEs)	Up to 55 days
Number of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations and clinical laboratory tests	Up to 55 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2019
• Primary Completion (ACTUAL): February 10, 2020
• Study Completion (ACTUAL): February 10, 2020

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (ACTUAL): October 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: MB006-017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No