Study Complete
Sponsor ID
20150186
AMG 986 20150186 Renal Impairment Study
Study Details
A study to assess the safety, tolerability, and pharmacokinetics of AMG 986 given orally as a single dose to healthy subjects and subjects with severely impaired kidney function.
Protocol Summary
Primary Outcome Measures
AMG 986 PK parameters - Area under the plasma concentration time curve from time 0 to the time of the last quantifiable sample
Timeframe: Day 1 to Day 6
AMG 986 PK parameters - Maximum observed plasma concentration after dosing
Timeframe: Day 1 to Day 6
AMG 986 PK parameters -Terminal phase half-life
Timeframe: Day 1 to Day 6
AMG 986 PK parameters - Time of maximum plasma concentration
Timeframe: Day 1 to Day 6
AMG 986 PK parameters - AUC from time 0 to infinity
Timeframe: Day 1 to Day 6
Secondary Outcome Measures
Adverse Event assessment
Timeframe: 58 days
Change in Heart rate
Timeframe: 58 days
Physical Examination Assessment
Timeframe: 58 days
Change in total Creatine kinase
Timeframe: 58 days
ECG assessments
Timeframe: 58 days
Change in Blood Pressure
Timeframe: 58 days
Change in Respiratory rate
Timeframe: 58 days
Change in Troponin 1
Timeframe: 58 days
Change in total bilirubin
Timeframe: 58 days
Change in alanine aminotransferase
Timeframe: 58 days
Change in Aspartate aminotransferase
Timeframe: 58 days
Locations
Location
Research Site
Orlando, FL, United States, 32809
Status
Recruiting
Location
Research Site
Minneapolis, MN, United States, 55404
Status
Recruiting
Location
Research Site
Tustin, CA, United States, 92780
Status
Recruiting
Location
Research Site
San Antonio, TX, United States, 78215
Status
Recruiting