NCT00659555已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pazopanib exposure measured by AUC anc Cmax.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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.
- •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.
研究组 & 干预措施
Treatment A receivers
Experimental
Subjects received pazopanib, single dose as 2 x 40 microliter drops of 5 mg/mL solution in Period 1
干预措施: pazopanib eye drops (Drug)
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
干预措施: pazopanib eye drops (Drug)
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
干预措施: Ketoconozole tablets (Drug)
结局指标
主要结局
Pazopanib exposure measured by AUC anc Cmax.
时间窗: Up to 2 months
次要结局
- General safety measured by clinical laboratory tests, vital signs, cardiac monitoring and AE reporting. Pazopanib exposure as measured by additional pharmacokinetic parameters.(Up to 2 months)
- Additional pharmacokinetic endpoints will include pazopanib AUC(0-t), tmax ans t½.(Up to 2 months)
研究者
研究点 (1)
Loading locations...
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