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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04649710
• Other study ID #: MB130-063
• Status: Withdrawn
• Phase: Phase 1
• Start date: June 21, 2021
• Est. completion date: September 22, 2021

Study information

• Verified date: April 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 22, 2021
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants
• Overweight

Intervention

Biological:
• BMS-986036
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
China	Local Institution	Changchun	Jilin
Korea, Republic of	Local Institution	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Incidence of adverse events (AEs)		Up to 45 days
Secondary	Incidence of serious adverse events (SAEs)		Up to 70 days
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 64 days
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 64 days
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 64 days
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 64 days
Secondary	Incidence of clinically significant changes in physical examination findings		Up to 64 days
Secondary	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	Up to 64 days
Secondary	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	Up to 64 days
Secondary	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	Up to 64 days
Secondary	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	Up to 64 days
Secondary	Incidence of clinically significant changes in clinical laboratory values: Hematology tests		Up to 64 days
Secondary	Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests		Up to 64 days
Secondary	Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests		Up to 64 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls