Macular DegenerationPhase 1NCT00659555
Study Of The Repeat Dosing Of Ketoconazole On The Pharmacokinetics Of A Single Dose Of Pazopanib (GW786034) Eye Drops
A Phase 1 study testing pazopanib eye drops and Ketoconozole tablets in people with Macular Degeneration, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This is a two-period study to evaluate the effect of repeat oral dosing of ketoconazole on the pharmacokinetics of single dose pazopanib administered as an eye drop Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- pazopanib eye drops and Ketoconozole tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2008to 10 May 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy as determined by a trained health care professional, base on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. 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. Subjects with ALT or AST values above the normal limit should be excluded from enrollment.
- Male or female greater than 18 years of age.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a document tubal ligation/occlusion or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample showing simultaneous follicle stimulating hormone (FSH)> 40MIU/ml and estradiol < 40 pg/ml (<140 pmol/L) may be used to confirm that a woman is postmenopausal].
- BMI within the range 18-30 kg/m2 (inclusive).
- Capable of giving written informed consent and complying with the requirements and restrictions listed in the consent form.
- QTcB or QTcF < 450 msec; or QTc <480 msec in subjects with Bundle Branch Block.
Who cannot join
- Current alcohol or illicit drug use which, in the judgment of the Investigator, would interfere with the subject's ability to comply with the dosing schedule or protocol-specified evaluations. For example, a history of regular alcohol consumption (defined below) within 6 months of screening would exclude a subject.
- Regular alcohol consumption: an average weekly intake of >14 drinks/week for men or > 7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- HIV requiring treatment during the study period.
- 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.
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- Use of prescription, non-prescription, or illicit drugs, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and the GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. (Note: this restriction includes ocular prescription and non-prescription drugs.)
- 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.
- Any contraindication to use of ketoconazole as detailed in the package insert.
- Where participation in the study would result in donation of blood or blood products in excess of 500 ml within a 56 day period.
- Pregnant females as determined by positive urine hCG test at screening or prior to dosing.
- Women planning to breastfeed an infant during the study period.
- Presence of ongoing ocular disease at the time of screening.
- Any eye surgery within three months prior to first dose of study medication.
- An unwillingness to refrain from wearing contact lenses during the study until completion of the follow-up visit.
- Urinary continine 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 (found in orange marmalade), grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Two-period, Fixed-sequence Study in Healthy Volunteers to Evaluate the Effects of Repeat Oral Dosing of Ketoconazole on the Pharmacokinetics of a Single Dose of Pazopanib (GW786034) Administered as Eye Drops
This is a two-period study to evaluate the effect of repeat oral dosing of ketoconazole on the pharmacokinetics of single dose pazopanib administered as an eye drop
- Conditions
- Macular Degeneration
- Being tested
- pazopanib eye drops, Ketoconozole tablets
- Keywords
- vascular endothelial growth factor,, drug interaction,, pharmacokinetics,, age-related macular degeneration,, pazopanib,, angiogenesis,, ketoconazole
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pazopanib eye dropsDrug
Pazopanib will be administered as eye drop solution via topical ocular route. Pazopanib eye drops will be available as white, colorless solution.
Ketoconozole tabletsDrug
Ketoconozole will be administered as tablets via oral route. Ketoconozole tablets will be present as white, rounded, scored tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment A receivers | Experimental | Subjects received pazopanib, single dose as 2 x 40 microliter drops of 5 mg/mL solution in Period 1 Receives: Drug: pazopanib eye drops |
| Treatment B receivers | Experimental | Subjects received ketoconazole, daily 400 mg oral dose on Days 1 to 8; pazopanib, single dose as 2 x 40 microliter drops of 5 mg/mL solution on Day 5 in Period 2 Receives: Drug: pazopanib eye drops; Drug: Ketoconozole tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pazopanib exposure measured by AUC anc Cmax.
Measured: Up to 2 months
Secondary outcomes (2)
General safety measured by clinical laboratory tests, vital signs, cardiac monitoring and AE reporting. Pazopanib exposure as measured by additional pharmacokinetic parameters.
Measured: Up to 2 months
Additional pharmacokinetic endpoints will include pazopanib AUC(0-t), tmax ans t½.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study start4 Apr 2008
- Primary completion10 May 2008
- Study completion10 May 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659555
- Sponsor's protocol ID
- MD7110861
- Status last verified
- Nov 2017
- First submitted
- 10 Apr 2008
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Two-period, Fixed-sequence Study in Healthy Volunteers to Evaluate the Effects of Repeat Oral Dosing of Ketoconazole on the Pharmacokinetics of a Single Dose of Pazopanib (GW786034) Administered as Eye Drops
- ClinicalTrials.gov ID
- NCT00659555
- Acronym / sponsor ID
- MD7110861
- Conditions
- Macular Degeneration
- Keywords
- vascular endothelial growth factor,, drug interaction,, pharmacokinetics,, age-related macular degeneration,, pazopanib,, angiogenesis,, ketoconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2008 (actual)
- Primary completion
- 10 May 2008 (actual)
- Study completion
- 10 May 2008 (actual)
- First posted
- 16 Apr 2008 (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.
This is a two-period study to evaluate the effect of repeat oral dosing of ketoconazole on the pharmacokinetics of single dose pazopanib administered as an eye drop
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A receivers | Experimental | Drug: pazopanib eye dropsSubjects received pazopanib, single dose as 2 x 40 microliter drops of 5 mg/mL solution in Period 1 |
| Treatment B receivers | Experimental | Drug: pazopanib eye drops, Drug: Ketoconozole tabletsSubjects received ketoconazole, daily 400 mg oral dose on Days 1 to 8; pazopanib, single dose as 2 x 40 microliter drops of 5 mg/mL solution on Day 5 in Period 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy as determined by a trained health care professional, base on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. 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. Subjects with ALT or AST values above the normal limit should be excluded from enrollment.
- Male or female greater than 18 years of age.
- A female subject is eligible to participate if she is of:
- BMI within the range 18-30 kg/m2 (inclusive).
- Capable of giving written informed consent and complying with the requirements and restrictions listed in the consent form.
Key exclusion criteria (17 listed)
- Current alcohol or illicit drug use which, in the judgment of the Investigator, would interfere with the subject's ability to comply with the dosing schedule or protocol-specified evaluations. For example, a history of regular alcohol consumption (defined below) within 6 months of screening would exclude a subject.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- HIV requiring treatment during the study period.
- 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.
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 |
|---|---|---|
| pazopanib eye dropsPazopanib will be administered as eye drop solution via topical ocular route. Pazopanib eye drops will be available as white, colorless solution. | Drug | Treatment A receivers, Treatment B receivers |
| Ketoconozole tabletsKetoconozole will be administered as tablets via oral route. Ketoconozole tablets will be present as white, rounded, scored tablets | Drug | Treatment B receivers |
Primary outcome
Pazopanib exposure measured by AUC anc Cmax.
Time frame: Up to 2 months
2 secondary outcomes
General safety measured by clinical laboratory tests, vital signs, cardiac monitoring and AE reporting. Pazopanib exposure as measured by additional pharmacokinetic parameters.
Time frame: Up to 2 months
Additional pharmacokinetic endpoints will include pazopanib AUC(0-t), tmax ans t½.
Time frame: Up to 2 months
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 13 Nov 2017.
- Results for study 110861 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pazopanib eye drops and Ketoconozole tablets in people with Macular Degeneration, run by GlaxoSmithKline at 1 site in United States.
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 7 inclusion and 17 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 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Pazopanib exposure measured by AUC anc Cmax. (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
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 13 Nov 2017.