| Trial ID: | L1328 |
| Source ID: | NCT02902679
|
| Associated Drug: |
Bms-986177
|
| Title: |
A Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Thrombosis|Factor XI|Renal Impairment|ESRD (End-Stage Renal Disease)
|
| Interventions: |
DRUG: BMS-986177
|
| Outcome Measures: |
Primary: To assess the Number of subjects with Adverse events (AEs)., Day -1 - day 3|To assess the Change from baseline in Physical examination parameters., Day -1 - day 3|To assess the change from baseline in Electrocardiogram (ECG) assessment., Day -1 - day 3|To assess the change from baseline in clinical laboratory values., Day -1 - day 3|To assess the change from baseline in vital signs assessment., Day -1 - day 3 | Secondary: To assess the change from baseline in activated partial thromboplastin time (aPTT)., Day -1 - day 3|To assess the change from baseline in Factor XI clotting activity (FX1c )., Day -1 - day 3
|
| Sponsor/Collaborators: |
Sponsor: Bristol-Myers Squibb
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
6
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-11
|
| Completion Date: |
2017-06
|
| Results First Posted: |
|
| Last Update Posted: |
2017-07-27
|
| Locations: |
Orlando Clinical Research Center, Orlando, Florida, 32809, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02902679
|
