Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Conditions
Brief summary
This is a study of experimental medication BMS-986036 given to healthy participants.
Interventions
DRUGBMS-986036
Crossover administration to abdomen then upper arm
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 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 participant, as determined by no clinically significant deviations from normal in medical history, physical examination, ECGs, and clinical laboratory determinations * BMI of 18 to ≤ 40 kg/m2
Exclusion criteria
* Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds) * Any bone trauma (fracture) or bone surgery (i.e. hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration * Known or suspected autoimmune disorder, excluding vitiligo * Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status * Any significant acute or chronic medical illness * Current or recent (within 3 months of study drug administration) gastrointestinal disease * Any major surgery within 6 weeks of study drug administration * History of diabetes mellitus Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed serum concentration (Cmax) | 29 days |
| Time of maximum observed serum concentration (Tmax) | 29 days |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)] | 29 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(0-inf)] | 29 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of deaths | Up to 78 days |
| Number of injection site reactions | Up to 78 days |
| Serum biomarker antibody concentration | Up to 78 days |
| Number of adverse events (AE) | Up to 78 days |
| Number of serious adverse events (SAE) | Up to 78 days |
| Number of AEs leading to discontinuation | Up to 78 days |
Countries
United States
Outcome results
None listed