- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01072214
A Safety Study to Evaluate Pazopanib Eye Drops in Healthy Volunteers
A Randomized, Placebo-controlled, Double-masked, Parallel Group Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Repeat Doses of Pazopanib Eye Drops in Healthy Adult Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Glendale, California, United States, 91206
- GSK Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- AST, ALT, alkaline phosphatase and bilirubin ≤ 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.
- Male or female ≥ 20 to 64 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) is confirmatory
- Body weight ≥ 50 kg for men and ≥ 45 kg for women and body mass index (BMI) within the range 18.5 - 32 kg/m2 (inclusive), where BMI = (weight in kg)/(height in meters)2.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Average 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.
Exclusion Criteria:
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of clinically relevant coronary heart disease, uncontrolled hypertension, renal disease, diabetes mellitus, impaired endocrine, thyroid, or respiratory function, or psychotic mental illness
- History of any hemorrhagic event (hemoptysis, cerebral or gastrointestinal) within 6 months of screening
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months of screening.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive pre-study drug/alcohol screen
- A positive test for HIV antibody
- Blood pressure (SBP/DBP) > 140/90 mmHg at screening
- History of dry eye or presence of any active ocular disease at time of screening that the investigator and medical monitor agree may cause additional risk to the subject or may interfere with study assessments or endpoints
- Any eye surgery within three months prior to first dose of study medication
- Use of ocular prescription or non-prescription drugs within 7 days prior to the first dose of study medication
- Prior history of ocular allergy, unless symptom-free for at least 6 months from first dose.
- An unwillingness to refrain from wearing contact lenses during the study and up to 2 weeks before the study start
- 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
- History of regular alcohol consumption within 6 months of the study defined as:
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
- Participation in a clinical trial where the subject has received an investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer) prior to the first dose of study medication
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice within 7 days prior to the first dose of study medication
- 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
- For Cohort 3, the following additional inclusion criterion applies:
Subject must have spent most of his or her life in Japan and not have lived outside of Japan for more than 5 years. They must have been born in Japan with four ethnic Japanese grandparents.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1.6 mg
The actual dosage is 10 mg/ml (GW786034) given 4 times a day for a maximum daily dosage of 1.6mg
|
gw786034
|
Experimental: TBD COHORT 2
Dose escalation amount to be determined (TBD) after results from Cohort 1 analyzed
|
gw786034
|
Placebo Comparator: Placebo
Subjects will receive placebo (drops without drug).
|
placebo
|
Experimental: TBD COHORT 3
Dose escalation amount to be determined (TBD) after results from Cohort 2 analyzed
|
gw786034
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical safety data from AE reporting, clinical observations, physical examinations, vital signs (blood pressure and heart rate), clinical laboratory tests including urinalysis, general ophthalmic examinations, and best-corrected visual acuity tests
Time Frame: 2 weeks
|
2 weeks
|
Primary pharmacokinetic endpoints will include: AUC(0-24), Cmax after repeat administration of pazopanib ophthalmic solution, Tmax, and trough steady-state plasma pazopanib concentration (Cτ)
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary pharmacokinetic parameters include: area under the plasma drug concentration versus time curve [AUC(0-t)], observed accumulation ratio (Ro), and apparent terminal half-life (t1/2) after repeat administration will be analyzed
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 113748
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Macular Degeneration
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationChina
-
Hoffmann-La RocheWithdrawnNeovascular Age-Related Macular DegenerationDenmark, Argentina, Hong Kong, Thailand, Portugal, Greece, Spain
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationSpain, Italy, Germany, Canada, Ireland
-
Novartis PharmaceuticalsTerminatedNeovascular Age-Related Macular Degeneration
-
Regeneron PharmaceuticalsCompletedNeovascular Age Related Macular DegenerationUnited States
-
Hoffmann-La RocheRecruitingNeovascular Age Related Macular Degeneration | nAMDChina
-
Shanghai Refreshgene Technology Co., Ltd.RecruitingNeovascular Age-related Macular DegenerationChina
-
PharmAbcineC&R Research, Inc.RecruitingNeovascular Age-related Macular DegenerationKorea, Republic of
-
Olix Pharmaceuticals, Inc.Trial Runners, LLCRecruitingNeovascular Age-related Macular DegenerationUnited States
-
Seoul National University Bundang HospitalRecruitingNeovascular Age-related Macular DegenerationKorea, Republic of
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States