Trials / Completed
CompletedNCT00748046
Alpharadin™ (Radium-223 Chloride) Safety and Dosimetry With HRPC That Has Metastasized to the Skeleton
Phase 1, Open-label, Single Ascending-dose Study to Assess Safety, Pharmacokinetics, Biodistribution and Radiation Dosimetry of Intravenous Doses of Alpharadin™ Injection (Radium-223 Chloride) in Patients With HRPC and Skeletal Metastases
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry and pharmacokinetics of three intravenous escalating dose levels of Xofigo (Alpharadin).
Detailed description
Within the U.S., the trial is conducted under an IND sponsored by Bayer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Radium-223 chloride (BAY88-8223) | The required volume of study drug to be administered to a patient was calculated using the patient's body weight. |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2009-10-01
- Completion
- 2009-10-01
- First posted
- 2008-09-08
- Last updated
- 2014-06-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00748046. Inclusion in this directory is not an endorsement.