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An Explorative Study on the Pharmacokinetics and Pharmacodynamics of Sunitinib in Healthy Volunteers

NCT00904657 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2009-12-04

No results posted yet for this study

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

  • Blood Pressure

Interventions

DRUG

sunitinib (Sutent)

50 mg capsule Sutent, one application a day for five days

Sponsors & Collaborators

  • University Hospital, Bonn

    collaborator OTHER

  • ZKS Köln

    collaborator OTHER

  • University of Cologne

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-04-30
Completion
2009-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00904657 on ClinicalTrials.gov