| Trial ID: | L0153 |
| Source ID: | NCT03674476
|
| Associated Drug: |
BMS-986036
|
| Title: |
An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NAFLD|Nonalcoholic Fatty Liver Disease|Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: BMS-986036
|
| Outcome Measures: |
Maximum observed serum concentration (Cmax) of C-terminal intact BMS-986036|Time of maximum observed serum concentration (Tmax) of C-terminal intact BMS-986036|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|Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036|Terminal elimination half-life (T-half) of C-terminal intact BMS-986036|Apparent total body clearance (CLT/F) of C-terminal intact BMS-986036|Apparent volume of distribution (Vz/F) of C-terminal intact BMS-986036|Total renal clearance (CLR) of C-terminal intact BMS-986036|Amount per fraction excreted into urine (Fe) of C-terminal intact BMS-986036|Total amount excreted into urine (Ae) of C-terminal intact BMS-986036|Maximum observed serum concentration (Cmax) of total BMS-986036|Time of maximum observed serum concentration (Tmax) of total BMS-986036|Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of total BMS-986036|Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of total BMS-986036|Terminal elimination half-life (T-half) of total BMS-986036|Apparent total body clearance (CLT/F) of total BMS-986036|Apparent volume of distribution (Vz/F) of total BMS-986036|Total renal clearance (CLR) of total BMS-986036|Amount per fraction excreted into urine (Fe) of total BMS-986036|Total amount excreted into urine (Ae) of total BMS-986036|Incidence of injection site reactions (prospective)|Incidence of adverse events (AE)|Incidence of serious adverse events (SAE)|Incidence of clinically significant changes to events of special interest
|
| Sponsor/Collaborators: |
Bristol-Myers Squibb
|
| Gender: |
All
|
| Age: |
21 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
40
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
September 11, 2018
|
| Completion Date: |
June 24, 2019
|
| Results First Posted: |
--
|
| Last Update Posted: |
October 8, 2019
|
| Locations: |
Pharmaceutical Research Associates CZ, s.r.o, Praha 7, Czechia|PRA Magyarorszag Kft, Budapest, Hungary|Semmelweis Egyetem, Budapest, Hungary|Clinical Research Unit Hungary, Miskolc, Hungary
|
| URL: |
https://ClinicalTrials.gov/show/NCT03674476
|
