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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986036


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |