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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: BMS-986036

Study type

Interventional

Funder types

Industry

Identifiers

NCT04493567

MB130-101

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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/exclusion criteria apply