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

Primary Purpose

Obese But Otherwise Healthy Participants

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-963272
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obese But Otherwise Healthy Participants

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • PRA Health Sciences - Lenexa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

BMS-963272 or Placebo once daily (QD)

BMS-963272 or Placebo every 12 hours (Q12H)

BMS-963272 or Placebo every 8 hours (Q8H)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Number of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations and clinical laboratory tests

Full Information

First Posted
October 3, 2019
Last Updated
May 14, 2020
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04116632
Brief Title
A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults
Official Title
A Multiple Dose Pharmacokinetic/Pharmacodynamic and Safety and Tolerability Study of BMS-963272 in Obese But Otherwise Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
February 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese But Otherwise Healthy Participants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-963272 or Placebo once daily (QD)
Arm Type
Experimental
Arm Title
BMS-963272 or Placebo every 12 hours (Q12H)
Arm Type
Experimental
Arm Title
BMS-963272 or Placebo every 8 hours (Q8H)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-963272
Intervention Description
Single dose with varying frequency among groups
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration of BMS-963272 (Cmax)
Time Frame
Day 1, Day 14
Title
Time of maximum observed concentration of BMS-963272 (Tmax)
Time Frame
Day 1, Day 14
Title
Area under the concentration-time curve in one dosing interval (AUC(TAU))
Time Frame
Day 1, Day 14
Title
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Time Frame
Day 14
Title
Apparent total clearance of the drug from plasma after oral administration (CLss/F)
Time Frame
Day 14
Title
Apparent volume of distribution at steady state (Vss/F)
Time Frame
Day 14
Title
Average concentration at steady state (Cavg,ss)
Time Frame
Day 14
Title
Half-life (T-HALF)
Time Frame
Day 14
Title
Accumulation index (AI)
Time Frame
Day 14
Title
Rate elimination constant (kel) of BMS-963272
Time Frame
Day 14
Title
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
Title
Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT
Time Frame
Day 7, Day 15
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs)
Time Frame
Up to 55 days
Title
Incidence of Serious Adverse Events (SAEs)
Time Frame
Up to 55 days
Title
Number of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations and clinical laboratory tests
Time Frame
Up to 55 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
PRA Health Sciences - Lenexa
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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