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

NCT00904657 | Completed Phase 1 DMC

• 1 other identifier: Uni-Koeln-1127
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

pharmacokinetic/pharmacodynamic modeling; biomarkers (growth factors) as a possible tool of drug effect

Interventions

sunitinib (Sutent) DRUG

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian
• Male/Female
• Age: 18-55 years
• Body weight of 60 kg or higher, Body Mass Index 19 - 27 kg/m2
• Considered to be healthy on the basis of extensive pre-study screening
• Willing and capable to confirm written consent to enrolment after ample information has been provided

You may not qualify if:

• Ongoing healing of wound or parenchymal tissue requiring angiogenesis
• Any skin abnormality and/or neurodermatitis and /or chronic skin disease
• A history of haemorrhage
• A history of any gastrointestinal event with persisting clinical relevance
• A history of pancreatitis
• History of cerebrovascular accident or transient ischemic attack or seizures
• History of pulmonary embolism
• History of venous thromboembolic events
• History of hypertension
• A history of cardiac events within 12 months prior to sunitinib administration such as myocardial infarction (including severe/unstable angina), coronary/peripheral artery bypass graft
• Any relevant clinical abnormality (as based on extensive medical history, amination, vital signs and 12-lead ECG)
• Inadequate cardiac function \[left ventricular ejection fraction (LVEF) \< lower limit of normal (LLN) as assessed by echocardiography (ECHO)\]
• A history of any surgical abdominal intervention (including appendectomy) or of peritonitis
• Bronchial asthma, COPD, or actual obstructive bronchitis
• Hypothyroidism /hyperthyroidism

Sponsors & Collaborators

• University of Cologne: lead
• University Hospital, Bonn: collaborator
• ZKS Köln: collaborator

MeSH Terms

Interventions

Sunitinib

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 20, 2009
• Study Start: October 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 4, 2009

Record last verified: 2009-12