Study Complete
Sponsor ID
20080676

Pharmacokinetics Study of AMG 423 in Healthy Subjects and Subjects with Various Degrees of Renal Insufficiency

Sponsor ID
20080676
Clinicaltrials.gov ID
NCT01737866
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

A phase 1, open-label study in subjects with normal renal function and subjects with various degrees of renal insufficiency, including patients with end-stage renal disease (ESRD) requiring hemodialysis. The primary objective is to evaluate the single-dose PK of AMG 423 in subjects with various degrees of renal insufficiency, including patients with end-stage renal disease requiring hemodialysis.

Additional Study Details

Phase
Phase 1
Product
AMG 423
Type
Interventional
Masking
None (Open Label)
Enrollment
13
Additional Study Details

Protocol Summary

Primary Outcome Measures

AMG 423 Pharmacokinetic Parameters

Timeframe: Twenty time points, up to eight days

Secondary Outcome Measures

Other Total AMG 423 PK Parameters

Timeframe: Twenty time points, up to eight days

AMG 423 Dialysis Clearance

Timeframe: Hours 4, 5, 6, 7 & 8 post-dose

AMG 423 Metabolites

Timeframe: Twenty time points, up to eight days

Safety

Timeframe: Up to 46 days, including a 28 day screening period

Locations

Location
Status
Contact Us
Location
Research Site
Orlando, FL, United States, 32809
Status
Recruiting