Blood PressurePhase 1NCT00904657
An Explorative Study on the Pharmacokinetics and Pharmacodynamics of Sunitinib in Healthy Volunteers
A Phase 1 study testing sunitinib (Sutent) in people with Blood Pressure, run by University of Cologne.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- sunitinib (Sutent)
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: An Open-label One-way Explorative Study on the Pharmacokinetics and Pharmacodynamics of Sunitinib in Healthy Volunteers
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
- Being tested
- sunitinib (Sutent)
- Keywords
- pharmacokinetic/pharmacodynamic modeling, biomarkers (growth factors) as a possible tool of drug effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib (Sutent)Drug
50 mg capsule Sutent, one application a day for five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startOct 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bonn, ZKS Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904657
- Sponsor's protocol ID
- Uni-Koeln-1127
- Status last verified
- Dec 2009
- First submitted
- 19 May 2009
- Last updated
- 4 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label One-way Explorative Study on the Pharmacokinetics and Pharmacodynamics of Sunitinib in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00904657
- Acronym / sponsor ID
- Uni-Koeln-1127
- Conditions
- Blood Pressure
- Keywords
- pharmacokinetic/pharmacodynamic modeling, biomarkers (growth factors) as a possible tool of drug effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- University Hospital, Bonn, ZKS Köln
- Study start
- Oct 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (43 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sunitinib (Sutent)50 mg capsule Sutent, one application a day for five days | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sunitinib (Sutent) in people with Blood Pressure, run by University of Cologne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2009.