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

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT04493567

Run by

Bristol-Myers Squibb

People needed

102

Starts

2020-07-29

Expected to finish

2021-06-11

Last updated by the study team

2022-03-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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