Clinical trial NCT04493567: Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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: 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

Primary outcomes:
measure: Maximum observed serum concentration (Cmax)
timeFrame: Up to 29 days
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
timeFrame: Up to 29 days
measure: Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036
timeFrame: Up to 29 days
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 115 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to 85 days
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: Up to 85 days
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Up to 85 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 85 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 85 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 85 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 85 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
timeFrame: Up to 85 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
timeFrame: Up to 85 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
timeFrame: Up to 85 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
timeFrame: Up to 85 days
measure: Incidence of clinically significant changes in physical examination findings
timeFrame: Up to 85 days
measure: Number of participants with local injection site reactions
timeFrame: Up to 57 days
measure: Number of participants with Antibodies to fibroblast growth factor 21 (FGF21)
timeFrame: Up to 57 days
measure: Number of participants with Antibodies to BMS-986036
timeFrame: Up to 57 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Salt Lake City
country: United States
facility: ICON (LPRA) - Salt Lake
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: