Clinical trial NCT04649710: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Chinese
Ethnicity
Korean
Obese
Overweight
Pegbelfermin
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of C-terminal intact BMS-986036 in Chinese and Korean participants
timeFrame: Up to 7 days after first dose and up to 7 days after last dose
measure: Time of maximum observed plasma concentration (Tmax) of C-terminal intact BMS-986036 in Chinese and Korean participants
timeFrame: Up to 7 days after first dose and up to 7 days after last dose
measure: Area under the concentration-time curve over 1 dosing interval (AUC (TAU)) of C-terminal intact BMS-986036 in Chinese and Korean participants
timeFrame: Up to 7 days after first dose and up to 7 days after last dose
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 45 days
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 70 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 64 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 64 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 64 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 64 days
measure: Incidence of clinically significant changes in physical examination findings
timeFrame: Up to 64 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
timeFrame: Up to 64 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS
timeFrame: Up to 64 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
timeFrame: Up to 64 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF
timeFrame: Up to 64 days
measure: Incidence of clinically significant changes in clinical laboratory values: Hematology tests
timeFrame: Up to 64 days
measure: Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
timeFrame: Up to 64 days
measure: Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
timeFrame: Up to 64 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: Local Institution
state: Jilin
city: Busan
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: