Study Complete
Sponsor ID
20070885

A Phase 1 Multiple Dose Study to Compare the Effects of AMG 223 and Sevelamer HCL (Renagel®)

Sponsor ID
20070885
Clinicaltrials.gov ID
NCT00756860
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The purpose of this study is to determine if subjects on 2g AMG 223 will achieve 60% or greater reduction in urinary phosphorus from baseline compared to subjects on 2g Renagel®.

Renagel®, Sevelamer HCl is currently the market leader for the treatment of hyperphosphatemia in patients on dialysis.

Additional Study Details

Phase
Phase 1
Product
bixalomer
Type
Interventional
Masking
None (Open Label)
Enrollment
66
Additional Study Details

Protocol Summary

Primary Outcome Measures

To compare the effects of 2g AMG 223 and 2g Renagel® on 24 hour urinary phosphorous excretion after multiple doses in healthy volunteers.

Timeframe: Including the 28-day Screening period, the 15-day residency period, and the follow-up on Day 15 (one week after discharge from the clinical research unit), the maximum subject participation is approximately 50 days.

Secondary Outcome Measures

To compare the effects of 2g AMG 223 and 2g Renagel® on 24 hour fecal phosphorous excretion after multiple doses in healthy volunteers.

Timeframe: Including the 28-day Screening period, the 15-day residency period, and the follow-up on Day 15 (one week after discharge from the clinical research unit), the maximum subject participation is approximately 50 days.

To assess safety and tolerability of multiple doses of 2g AMG 223 in healthy volunteers.

Timeframe: Including the 28-day Screening period, the 15-day residency period, and the follow-up on Day 15 (one week after discharge from the clinical research unit), the maximum subject participation is approximately 50 days.

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.