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Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe

Primary Purpose

Healthy Participants

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986036
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Participants

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Healthy, overweight, obese, male and female participants, as determined by normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations
  • Body mass index (BMI) of 25.0 kg/m2 to 40.0 kg/m2, inclusive i) Approximately 25% of participants will be overweight and have a BMI between 25 kg/m2 and 30 kg/m2, inclusive ii) Approximately 75% of participants will be obese and have a BMI > 30 kg/m2 to ≤ 40 kg/m2
  • Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Inability to tolerate subcutaneous (SC) injections
  • Inability to be venipunctured and/or tolerate venous access
  • Any sound medical, psychiatric, and/or social reason as determined by the investigator

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • Anaheim Clinical Trials
  • ICON (LPRA) - Salt Lake

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe

Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe

Arm Description

Outcomes

Primary Outcome Measures

Maximum observed serum concentration (Cmax)
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036

Secondary Outcome Measures

Incidence of adverse events (AEs)
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Incidence of clinically significant changes in vital signs: Body temperature
Incidence of clinically significant changes in vital signs: Respiratory rate
Incidence of clinically significant changes in vital signs: Blood pressure
Incidence of clinically significant changes in vital signs: Heart rate
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
The PR interval is the time from the onset of the P wave to the start of the QRS complex.
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
The QT interval on the ECG is measured from the beginning of the QRS complex to the end of the T wave
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Corrected QT interval using Fridericia's formula (QTcF)
Incidence of clinically significant changes in physical examination findings
Number of participants with local injection site reactions
Number of participants with Antibodies to fibroblast growth factor 21 (FGF21)
Number of participants with Antibodies to BMS-986036

Full Information

First Posted
July 28, 2020
Last Updated
March 7, 2022
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04493567
Brief Title
Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe
Official Title
An Open-label, Randomized, Two-period Cross-over Study to Investigate the Relative Bioavailability of BMS-986036 in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 29, 2020 (Actual)
Primary Completion Date
June 11, 2021 (Actual)
Study Completion Date
June 11, 2021 (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
The purpose of this study is to develop an auto-injector (AI) device for the BMS-986036 subcutaneous formulation that can be self-administered conveniently by participants.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe
Arm Type
Experimental
Arm Title
Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986036
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Maximum observed serum concentration (Cmax)
Time Frame
Up to 29 days
Title
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time Frame
Up to 29 days
Title
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036
Time Frame
Up to 29 days
Secondary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Time Frame
Up to 115 days
Title
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame
Up to 85 days
Title
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame
Up to 85 days
Title
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame
Up to 85 days
Title
Incidence of clinically significant changes in vital signs: Body temperature
Time Frame
Up to 85 days
Title
Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame
Up to 85 days
Title
Incidence of clinically significant changes in vital signs: Blood pressure
Time Frame
Up to 85 days
Title
Incidence of clinically significant changes in vital signs: Heart rate
Time Frame
Up to 85 days
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Description
The PR interval is the time from the onset of the P wave to the start of the QRS complex.
Time Frame
Up to 85 days
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Description
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Time Frame
Up to 85 days
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Description
The QT interval on the ECG is measured from the beginning of the QRS complex to the end of the T wave
Time Frame
Up to 85 days
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Description
Corrected QT interval using Fridericia's formula (QTcF)
Time Frame
Up to 85 days
Title
Incidence of clinically significant changes in physical examination findings
Time Frame
Up to 85 days
Title
Number of participants with local injection site reactions
Time Frame
Up to 57 days
Title
Number of participants with Antibodies to fibroblast growth factor 21 (FGF21)
Time Frame
Up to 57 days
Title
Number of participants with Antibodies to BMS-986036
Time Frame
Up to 57 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 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: Healthy, overweight, obese, male and female participants, as determined by normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations Body mass index (BMI) of 25.0 kg/m2 to 40.0 kg/m2, inclusive i) Approximately 25% of participants will be overweight and have a BMI between 25 kg/m2 and 30 kg/m2, inclusive ii) Approximately 75% of participants will be obese and have a BMI > 30 kg/m2 to ≤ 40 kg/m2 Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial Exclusion Criteria: Women who are pregnant or breastfeeding Inability to tolerate subcutaneous (SC) injections Inability to be venipunctured and/or tolerate venous access Any sound medical, psychiatric, and/or social reason as determined by the investigator Other protocol-defined inclusion/exclusion criteria 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
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
ICON (LPRA) - Salt Lake
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
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.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe

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