Status:
COMPLETED
Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2021
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04493567
Start Date
July 29 2020
End Date
June 11 2021
Last Update
March 18 2022
Active Locations (2)
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1
Anaheim Clinical Trials
Anaheim, California, United States, 92801
2
ICON (LPRA) - Salt Lake
Salt Lake City, Utah, United States, 84124