Trials / Completed
CompletedNCT00756860
A Phase 1 Multiple Dose Study to Compare the Effects of AMG 223 and Sevelamer HCL (Renagel®)
A Phase 1 Multiple Dose Study to Compare the Effects of AMG 223 and Sevelamer HCL (Renagel®) on Phosphate Binding in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Amgen Research (Munich) GmbH · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 223 | 2 g AMG 223 (4 x 500 mg capsules ) TID on Days 1 through 7 |
| DRUG | Renagel® (sevelamer hydrochloride) | 2g Renagel® (2 x 800 mg capsules + 1 x 400 mg capsule) TID on Days 1 through 7 |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2008-08-01
- Completion
- 2009-09-01
- First posted
- 2008-09-22
- Last updated
- 2012-06-04
Source: ClinicalTrials.gov record NCT00756860. Inclusion in this directory is not an endorsement.