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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986036

• Registration Number: NCT04493567
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study Start: 2020-07-29
• Study First Posted: 2020-07-30
• Primary Completion: 2021-06-11
• Study Completion: 2021-06-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe	BMS-986036	-
Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe	BMS-986036	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of clinically significant changes in vital signs: Body temperature	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 BMS-986036	Up to 57 days
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: Respiratory rate	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	Up to 85 days	The 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: QRS interval	Up to 85 days	QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval	Up to 85 days	The QT interval on the ECG is measured from the beginning of the QRS complex to the end of the T wave
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval	Up to 85 days	Corrected QT interval using Fridericia's formula (QTcF)
Number of participants with Antibodies to fibroblast growth factor 21 (FGF21)	Up to 57 days
Incidence of clinically significant changes in vital signs: Blood pressure	Up to 85 days

Trial Locations

Locations (2)

ICON (LPRA) - Salt Lake; 🇺🇸 Salt Lake City, Utah, United States

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States