Last updated: 11/07/2018 06:23:58
A safety study in healthy volunteers to evaluate safety, how fast the drug is absorbed, and the side effects of the drug in humansNA
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A two-part study to evaluate the safety, tolerability and pharmacokinetics of single and repeat oral doses of pazopanib in healthy adult subjects
Trial description: 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.
Primary purpose:
Supportive Care
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Clinical safety data from AE reporting, clinical observations, physical exam findings, cardiac monitoring, vital signs, clinical laboratory tests, Pharmacokinetics, general ophthalmic examination and best-corrected visual acuity will be summarized.
Timeframe: 4 months
Secondary outcomes:
Pharmacokinetic parameters: AUC vs time curve after single dose; AUC vs time curve, trough plasma pazopanib concentration, accumulation ratio, and apparent terminal half-life after repeat dose will be analyzed, as data permit
Timeframe: 4 months
Interventions:
Enrollment:
72
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
McLaughlin M, Tucci-Paglione M, Slakter J, Tolentino M, Ye L, Xu C-F, Suttle B, Kim R. Initial Exploration of Oral Pazopanib in Healthy Subjects and Age-related Macular Degeneration Patients. JAMA Ophthal. 2013;131(12):1595-1601.
Medical condition
Macular Degeneration
Product
pazopanib
Collaborators
Not applicable
Study date(s)
January 2010 to May 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
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).
Trial location(s)
Location
GSK Investigational Site
Tacoma, Washington, United States, 98418
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2010-27-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study 113555 can be found on the GSK Clinical Study Register.
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