A Study to Evaluate the Drug Levels and Safety of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04649710

Collaborator

(none)

Enrollment

Locations

Arms

3.1

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Biological: BMS-986036 Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jun 21, 2021

Anticipated Primary Completion Date :

Sep 21, 2021

Anticipated Study Completion Date :

Sep 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1: Dose 1 or placebo Chinese participants	Biological: BMS-986036 Specified dose on specified days Other Names: Pegbelfermin Other: Placebo Specified dose on specified days
Experimental: Cohort 2: Dose 2 or placebo Chinese participants	Biological: BMS-986036 Specified dose on specified days Other Names: Pegbelfermin Other: Placebo Specified dose on specified days
Experimental: Cohort 3: Dose 1 or placebo Korean participants	Biological: BMS-986036 Specified dose on specified days Other Names: Pegbelfermin Other: Placebo Specified dose on specified days
Experimental: Cohort 4: Dose 2 or placebo Korean participants	Biological: BMS-986036 Specified dose on specified days Other Names: Pegbelfermin Other: Placebo Specified dose on specified days

Outcome Measures

Primary Outcome Measures

Maximum observed plasma concentration (Cmax) of C-terminal intact BMS-986036 in Chinese and Korean participants [Up to 7 days after first dose and up to 7 days after last dose]
Time of maximum observed plasma concentration (Tmax) of C-terminal intact BMS-986036 in Chinese and Korean participants [Up to 7 days after first dose and up to 7 days after last dose]
Area under the concentration-time curve over 1 dosing interval (AUC (TAU)) of C-terminal intact BMS-986036 in Chinese and Korean participants [Up to 7 days after first dose and up to 7 days after last dose]

Secondary Outcome Measures

Incidence of adverse events (AEs) [Up to 45 days]
Incidence of serious adverse events (SAEs) [Up to 70 days]
Incidence of clinically significant changes in vital signs: Body temperature [Up to 64 days]
Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 64 days]
Incidence of clinically significant changes in vital signs: Blood pressure [Up to 64 days]
Incidence of clinically significant changes in vital signs: Heart rate [Up to 64 days]
Incidence of clinically significant changes in physical examination findings [Up to 64 days]
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval [Up to 64 days]
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 [Up to 64 days]
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 [Up to 64 days]
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 [Up to 64 days]
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 [Up to 64 days]
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests [Up to 64 days]
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests [Up to 64 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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