Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe

Healthy Participants Clinical Trial

Official title:

An Open-label, Randomized, Two-period Cross-over Study to Investigate the Relative Bioavailability of BMS-986036 in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04493567
• Other study ID #: MB130-101
• Status: Completed
• Phase: Phase 1
• Start date: July 29, 2020
• Est. completion date: June 11, 2021

Study information

• Verified date: March 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 develop an auto-injector (AI) device for the BMS-986036 subcutaneous formulation that can be self-administered conveniently by participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 11, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Healthy, overweight, obese, male and female participants, as determined by normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations

• Body mass index (BMI) of 25.0 kg/m2 to 40.0 kg/m2, inclusive i) Approximately 25% of participants will be overweight and have a BMI between 25 kg/m2 and 30 kg/m2, inclusive ii) Approximately 75% of participants will be obese and have a BMI > 30 kg/m2 to = 40 kg/m2

• Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

• Women who are pregnant or breastfeeding

• Inability to tolerate subcutaneous (SC) injections

• Inability to be venipunctured and/or tolerate venous access

• Any sound medical, psychiatric, and/or social reason as determined by the investigator

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Healthy Participants
• Overweight

Intervention

Drug:
• BMS-986036
Specified dose on specified days

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	ICON (LPRA) - Salt Lake	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed serum concentration (Cmax)		Up to 29 days
Primary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]		Up to 29 days
Primary	Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036		Up to 29 days
Secondary	Incidence of adverse events (AEs)		Up to 115 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 85 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to 85 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 85 days
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 85 days
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 85 days
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 85 days
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 85 days
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval	The PR interval is the time from the onset of the P wave to the start of the QRS complex.	Up to 85 days
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval	QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization	Up to 85 days
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval	The QT interval on the ECG is measured from the beginning of the QRS complex to the end of the T wave	Up to 85 days
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval	Corrected QT interval using Fridericia's formula (QTcF)	Up to 85 days
Secondary	Incidence of clinically significant changes in physical examination findings		Up to 85 days
Secondary	Number of participants with local injection site reactions		Up to 57 days
Secondary	Number of participants with Antibodies to fibroblast growth factor 21 (FGF21)		Up to 57 days
Secondary	Number of participants with Antibodies to BMS-986036		Up to 57 days

External Links

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