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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-986036

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • ICON (LPRA) - Salt Lake

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe	Drug: BMS-986036; Specified dose on specified days
Experimental: Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe	Drug: BMS-986036; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed serum concentration (Cmax)	Up to 29 days
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]	Up to 29 days
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs)		Up to 115 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 85 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to 85 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 85 days
Incidence of clinically significant changes in vital signs: Body temperature		Up to 85 days
Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 85 days
Incidence of clinically significant changes in vital signs: Blood pressure		Up to 85 days
Incidence of clinically significant changes in vital signs: Heart rate		Up to 85 days
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
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
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
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval	Corrected QT interval using Fridericia's formula (QTcF)	Up to 85 days
Incidence of clinically significant changes in physical examination findings		Up to 85 days
Number of participants with local injection site reactions		Up to 57 days
Number of participants with Antibodies to fibroblast growth factor 21 (FGF21)		Up to 57 days
Number of participants with Antibodies to BMS-986036		Up to 57 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2020
• Primary Completion (Actual): June 11, 2021
• Study Completion (Actual): June 11, 2021

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: MB130-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No