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View Clinical Trial (Medical Research Study)
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A Safety Study in Healthy Volunteers to Evaluate Safety, How Fast the Drug is Absorbed, and the Side Effects of the Drug in Humans - NCT01051700-78744 (Clinical Trial 478856)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy478856.aspx
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| City: |
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Austin |
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State:
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TX |
| Zip Code: |
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78744 |
| Conditions: |
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Age Related Macular Degeneration |
| Purpose: |
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This study is to evaluate the safety, absorption rate and side effects associated with the
study drug. Healthy volunteers will be given a single dose of the drug in Part 1. Subjects
will be dosed at the same time at several different sites. In Part 2 of the study elderly
volunteers will participate in a 14 day repeat dose session receiving either study drug or a
placebo (sugar pill). Data from at least 7 days of safety will be reviewed from the first
set of volunteers before increasing the doses for the next set. All results will be used for
planning the next study.
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| Study summary: |
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The purpose of this study is to characterize more fully the safety, tolerability and
pharmacokinetics of single and repeat oral doses of pazopanib at lower doses than those
previously studied. The first part of the study is designed as an open-label,
non-randomized, single session, parallel-group, sequential dose-rising to investigate
pharmacokinetics of single oral doses in healthy adult subjects. In the second part of the
study, healthy elderly subjects will participate in one 14 day repeat-dose session,
randomized to receive either pazopanib or placebo. Dose escalation within Part 2, is based
upon emerging safety and PK data from each preceding repeat dosing cohort from at least 7
days of safety data as well as emerging safety and PK data from single dose. The elderly
population chosen for the second part of the study will more closely reflect the target
population for the AMD indication. The results from the current study will assist in the
dose selection of the subsequently planned study in patients with AMD. |
| Criteria: |
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Inclusion Criteria:
- AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated
bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin
<35%).
- Healthy as determined by a responsible and experienced physician, based on a medical
evaluation including medical history, physical examination, laboratory tests and
cardiac monitoring. A subject with a clinical abnormality or laboratory parameters
outside the reference range for the population being studied may be included only if
the Investigator and the GSK Medical Monitor agree that the finding is unlikely to
introduce additional risk factors and will not interfere with the study procedures.
- For the first part of the study male or female greater than or equal to 18 years of
age and for the second part male or female greater than or equal to 50 years of age
at the time of signing the informed consent.
- A female subject is eligible to participate if she is of non-childbearing potential
defined as pre-menopausal females with a documented tubal ligation or hysterectomy;
or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable
cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml
and estradiol < 40 pg/ml (<140 pmol/L) or values consistent with local laboratory
recommended value is confirmatory.
- Body weight greater than or equal to 50 kg for men and greater than or equal to 45 kg
for women within the BMI range 19-30 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.
- Single QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
- Best-corrected visual acuity better than 20/80 (Snellen equivalent) in both eyes in
Part 2 only.
Exclusion Criteria:
- History of clinically relevant impaired endocrine, thyroid, hepatic, respiratory or
renal function, uncontrolled hypertension, diabetes mellitus, coronary heart disease,
or psychotic mental illness.
- History of any clotting disorder, including predisposition to hypercoagulation or any
previous thromboembolic event.
- Elevations in blood pressure, based on criteria provided in Section 7.2.3. OR
Subjects with a blood pressure >140/90 mmHg, at screening.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary
abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined as: For
US sites: an average weekly intake of >14 drinks for males or >7 drinks for females.
One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150
ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
- The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first
dosing day.
- Use of prohibited medications as described in Section 9.2.
- History of sensitivity to any of the study medications, or components thereof or a
history of drug or other allergy that, in the opinion of the investigator or GSK
Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco-
or nicotine-containing products within 6 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days
prior to the first dose of study medication.
- Any prior intraocular surgery, excluding cataract surgery (Part 2 only)
- Any prior eye surgery within three months to first dose of study medication (Part 2
only). |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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