A Study to Evaluate the Drug Levels and Safety of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants
Phase 1
Withdrawn
- Conditions
- Healthy Participants
- Interventions
- Biological: BMS-986036Other: Placebo
- Registration Number
- NCT04649710
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: Dose 1 or placebo Placebo Chinese participants Cohort 2: Dose 2 or placebo Placebo Chinese participants Cohort 3: Dose 1 or placebo BMS-986036 Korean participants Cohort 1: Dose 1 or placebo BMS-986036 Chinese participants Cohort 2: Dose 2 or placebo BMS-986036 Chinese participants Cohort 3: Dose 1 or placebo Placebo Korean participants Cohort 4: Dose 2 or placebo Placebo Korean participants Cohort 4: Dose 2 or placebo BMS-986036 Korean participants
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 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 vital signs: Body temperature Up to 64 days Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests Up to 64 days Incidence of adverse events (AEs) Up to 45 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: 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 serious adverse events (SAEs) Up to 70 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: 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
Trial Locations
- Locations (1)
Local Institution
🇰🇷Busan, Korea, Republic of