Trials / Completed
CompletedNCT00904657
An Explorative Study on the Pharmacokinetics and Pharmacodynamics of Sunitinib in Healthy Volunteers
An Open-label One-way Explorative Study on the Pharmacokinetics and Pharmacodynamics of Sunitinib in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- University of Cologne · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The study is conducted: * to investigate the influence of sunitinib (study drug) on the plasma biomarkers VEGF-A, VEGF-C, soluble VEGFR-2, and soluble VEGFR-3 (vessel endothelial growth factors) and on the blood pressure; * to generate a pharmacokinetic/pharmacodynamic model for sunitinib using biomarkers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sunitinib (Sutent) | 50 mg capsule Sutent, one application a day for five days |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2009-04-01
- Completion
- 2009-04-01
- First posted
- 2009-05-20
- Last updated
- 2009-12-04
Source: ClinicalTrials.gov record NCT00904657. Inclusion in this directory is not an endorsement.