Back to resultsA Study to Evaluate the Drug Levels and Safety of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants
Primary Purpose
Healthy Participants
Status
Withdrawn
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-986036
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Participants focused on measuring Chinese, Ethnicity, Korean, Obese, Overweight, Pegbelfermin
Eligibility Criteria
Inclusion Criteria:
- Overweight and obese, but otherwise healthy Chinese and Korean participants, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- Additional criterion for Chinese participants: must be first generation Chinese (born in China and not living outside of China for > 10 years, and both parents are ethnically Chinese)
- Additional criterion for Korean participants: must be first generation Korean (born in Korea and not living outside of Korea for > 10 years, and both parents are ethnically Korean)
- Must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
- BMI ≥ 40 kg/m^2
- Women who are pregnant or breastfeeding
- History of allergy to pegylated compounds or fibroblast growth factor 21-related compounds
Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1: Dose 1 or placebo
Cohort 2: Dose 2 or placebo
Cohort 3: Dose 1 or placebo
Cohort 4: Dose 2 or placebo
Arm Description
Chinese participants
Chinese participants
Korean participants
Korean participants
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax) of C-terminal intact BMS-986036 in Chinese and Korean participants
Time of maximum observed plasma concentration (Tmax) of C-terminal intact BMS-986036 in Chinese and Korean participants
Area under the concentration-time curve over 1 dosing interval (AUC (TAU)) of C-terminal intact BMS-986036 in Chinese and Korean participants
Secondary Outcome Measures
Incidence of adverse events (AEs)
Incidence of serious adverse events (SAEs)
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 physical examination findings
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
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
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
The QT interval is the time from the start of the Q wave to the end of the T wave
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF
QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04649710
Brief Title
A Study to Evaluate the Drug Levels and Safety of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants
Official Title
A Double-Blind, Multicenter, Placebo-Controlled, Randomized, Parallel, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Business objectives have changed
Study Start Date
June 21, 2021 (Anticipated)
Primary Completion Date
September 21, 2021 (Anticipated)
Study Completion Date
September 22, 2021 (Anticipated)
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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and drug level of Pegbelfermin in healthy overweight and obese Chinese and Korean participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants
Keywords
Chinese, Ethnicity, Korean, Obese, Overweight, Pegbelfermin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: Dose 1 or placebo
Arm Type
Experimental
Arm Description
Chinese participants
Arm Title
Cohort 2: Dose 2 or placebo
Arm Type
Experimental
Arm Description
Chinese participants
Arm Title
Cohort 3: Dose 1 or placebo
Arm Type
Experimental
Arm Description
Korean participants
Arm Title
Cohort 4: Dose 2 or placebo
Arm Type
Experimental
Arm Description
Korean participants
Intervention Type
Biological
Intervention Name(s)
BMS-986036
Other Intervention Name(s)
Pegbelfermin
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) of C-terminal intact BMS-986036 in Chinese and Korean participants
Time Frame
Up to 7 days after first dose and up to 7 days after last dose
Title
Time of maximum observed plasma concentration (Tmax) of C-terminal intact BMS-986036 in Chinese and Korean participants
Time Frame
Up to 7 days after first dose and up to 7 days after last dose
Title
Area under the concentration-time curve over 1 dosing interval (AUC (TAU)) of C-terminal intact BMS-986036 in Chinese and Korean participants
Time Frame
Up to 7 days after first dose and up to 7 days after last dose
Secondary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Time Frame
Up to 45 days
Title
Incidence of serious adverse events (SAEs)
Time Frame
Up to 70 days
Title
Incidence of clinically significant changes in vital signs: Body temperature
Time Frame
Up to 64 days
Title
Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame
Up to 64 days
Title
Incidence of clinically significant changes in vital signs: Blood pressure
Time Frame
Up to 64 days
Title
Incidence of clinically significant changes in vital signs: Heart rate
Time Frame
Up to 64 days
Title
Incidence of clinically significant changes in physical examination findings
Time Frame
Up to 64 days
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Description
PR interval is the time from the onset of the P wave to the start of the QRS complex
Time Frame
Up to 64 days
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS
Description
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Time Frame
Up to 64 days
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Description
The QT interval is the time from the start of the Q wave to the end of the T wave
Time Frame
Up to 64 days
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF
Description
QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Time Frame
Up to 64 days
Title
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time Frame
Up to 64 days
Title
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Time Frame
Up to 64 days
Title
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Time Frame
Up to 64 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Overweight and obese, but otherwise healthy Chinese and Korean participants, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
Additional criterion for Chinese participants: must be first generation Chinese (born in China and not living outside of China for > 10 years, and both parents are ethnically Chinese)
Additional criterion for Korean participants: must be first generation Korean (born in Korea and not living outside of Korea for > 10 years, and both parents are ethnically Korean)
Must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
BMI ≥ 40 kg/m^2
Women who are pregnant or breastfeeding
History of allergy to pegylated compounds or fibroblast growth factor 21-related compounds
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
Local Institution
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
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 Study to Evaluate the Drug Levels and Safety of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants
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