Healthy Participants
Conditions
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.
Interventions
DRUGBMS-986036
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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/
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 adverse events (AEs) | Up to 115 days | — |
| 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) |
| 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 | — |
| 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 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 | — |
Countries
United States
Outcome results
None listed