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

This study has been completed.
Sponsor:
Collaborators:
University Hospital, Bonn
Zentrum für Klinische Studien Köln
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00904657
First received: May 19, 2009
Last updated: December 3, 2009
Last verified: December 2009
  Purpose

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.

Condition Intervention Phase
Blood Pressure
Drug: sunitinib (Sutent)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-label One-way Explorative Study on the Pharmacokinetics and Pharmacodynamics of Sunitinib in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Enrollment: 12
Study Start Date: October 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sunitinib (Sutent)
    50 mg capsule Sutent, one application a day for five days
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Cardiac insufficiency
  • Liver disease
  • Cardiac dysrhythmia (e.g., prolongation of the QT interval)
  • Diabetes mellitus
  • Chronic infections
  • Relevant acute infections or with actual therapy-requiring allergies (including drug allergies) within the last two weeks
  • Suspicion of hypersensitivity to sunitinib or to any of the excipients
  • Any clinically relevant laboratory abnormality
  • Subjects receiving any medication within 2 weeks prior to study start or during the study (exceptions possible upon decision of Principal Investigator, e.g., paracetamol (acetaminophen) single dose for acute pain or topical aciclovir for herpes simplex)
  • Subjects who have taken a drug with a long half-life (> 24 hours) within four weeks before the first trial day
  • Subjects who received chronic drug treatment (> 3 days) within eight weeks before the first trial day
  • Subjects who participated in a clinical trial within the last 3 months before the start of the present study
  • Subjects who donated blood or plasma within the last 12 weeks before the start of the present study
  • Subjects who smoke, i.e., subjects who smoked one or more cigarettes during the last six months
  • Subjects who are known or suspected to be (social) drug dependent, incl. those drinking more than 30 g alcohol per day
  • Subjects with a history of alcohol or recreational drug addiction
  • Subjects with a history of any severe disease that might interfere with the study objectives (e.g. psychiatric disease, epilepsy)
  • Subjects who are not willing or able to abstain from alcohol, methylxanthine-containing beverages and foods, and grapefruit flesh/juice for 72 hours before first study drug administration until 2 weeks after last study drug administration
  • Subjects who adhere to a special diet (e.g., vegetarians) or lifestyle (including working at night and extreme physical activities such as competitive sports and weight lifting) that might interfere with the investigation
  • Subjects planning elective hospital treatment within two months after last intake of trial medication
  • Subjects who are known or suspected not to comply with the study directives and/or known or suspected not to be reliable or trustworthy
  • Subjects who are known or suspected not to be capable of understanding and evaluating the information that is given to them as part of the formal information policy (informed consent), in particular regarding the foreseeable risks and discomfort to which they will be exposed
  • Subjects with anticipated problems of successfully placing an indwelling venous catheter at a forearm
  • Female subjects only:

    • positive results in pregnancy test
    • pregnant and lactating women
    • subjects who do not use or does not agree to use appropriate contraceptive methods during the study and two months after the study
  • Male subjects only: they have to accept not to procreate children during the study and two months after the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prof. Dr. Med. U. Fuhr, University of Cologne
ClinicalTrials.gov Identifier: NCT00904657     History of Changes
Other Study ID Numbers: Uni-Koeln-1127
Study First Received: May 19, 2009
Last Updated: December 3, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
pharmacokinetic/pharmacodynamic modeling
biomarkers (growth factors) as a possible tool of drug effect

Additional relevant MeSH terms:
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014