Study Complete
Sponsor ID
20150186

AMG 986 20150186 Renal Impairment Study

Sponsor ID
20150186
Clinicaltrials.gov ID
NCT03318809
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
AMG 986
Type
Interventional
Masking
None (Open Label)
Enrollment
12
Additional Study Details

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
Status
Contact Us
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