NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Conditions
Brief summary
This is an investigational study to evaluate the experimental medication BMS-986036 in participants with different levels of kidney function.
Interventions
DRUGBMS-986036
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * BMI ≥ 25 and ≤ 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 (ie, hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration * Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status * Any major surgery (eg, abdominal, thoracal, or cranial procedures) within 6 weeks of study drug administration * Donation of blood or plasma to a blood bank, or in a clinical study (except at the screening visit) within 6 weeks of study drug administration * Inability to tolerate subcutaneous injections Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed serum concentration (Cmax) of C-terminal intact BMS-986036 | Up to 30 days |
| Time of maximum observed serum concentration (Tmax) of C-terminal intact BMS-986036 | Up to 30 days |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of C-terminal intact BMS-986036 | Up to 30 days |
| Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036 | Up to 30 days |
| Terminal elimination half-life (T-half) of C-terminal intact BMS-986036 | Up to 30 days |
| Apparent total body clearance (CLT/F) of C-terminal intact BMS-986036 | Up to 30 days |
| Apparent volume of distribution (Vz/F) of C-terminal intact BMS-986036 | Up to 30 days |
| Total renal clearance (CLR) of C-terminal intact BMS-986036 | Up to 30 days |
| Amount per fraction excreted into urine (Fe) of C-terminal intact BMS-986036 | Up to 30 days |
| Total amount excreted into urine (Ae) of C-terminal intact BMS-986036 | Up to 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of injection site reactions (prospective) | Up to 30 days | — |
| Incidence of adverse events (AE) | Up to 30 days | — |
| Maximum observed serum concentration (Cmax) of total BMS-986036 | Up to 30 days | — |
| Incidence of clinically significant changes to events of special interest | Up to 30 days | Events of special interest include injection site assessment, AEs leading to discontinuation, and deaths as well as AEs related to marked abnormalities in clinical laboratory tests, vital sign measurements, electrocardiogram (ECGs), and physical examinations |
| Incidence of serious adverse events (SAE) | Up to 30 days | — |
| Time of maximum observed serum concentration (Tmax) of total BMS-986036 | Up to 30 days | — |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of total BMS-986036 | Up to 30 days | — |
| Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of total BMS-986036 | Up to 30 days | — |
| Terminal elimination half-life (T-half) of total BMS-986036 | Up to 30 days | — |
| Apparent total body clearance (CLT/F) of total BMS-986036 | Up to 30 days | — |
| Apparent volume of distribution (Vz/F) of total BMS-986036 | Up to 30 days | — |
| Total renal clearance (CLR) of total BMS-986036 | Up to 30 days | — |
| Amount per fraction excreted into urine (Fe) of total BMS-986036 | Up to 30 days | — |
| Total amount excreted into urine (Ae) of total BMS-986036 | Up to 30 days | — |
Countries
Czechia, Hungary
Outcome results
None listed