First Time in Human, Single Dose and Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK615915
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG)
研究概览
简要总结
GSK615915A is being developed as a novel surfactant for use in the formulation of GSK's future generation of Metered Dose Inhalers (MDIs). A surfactant in a MDI would provide a more stable drug suspension, this in turn will produce a consistent dose of drug being delivered with each puff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women of non-child bearing potential.
- •Body weight = 50 kg (110 lbs) for men and = 45 kg for women and Body Mass Index (BMI) within the range 19.0-30.0 kg/m²
- •The subject is a current non-smoker who has not used any tobacco products in the last 12 months with a pack history of = 10 pack years.
- •The subject has demonstrated the ability to correctly use a metered dose inhaler device.
- •If asthmatic:
- •The subject must be clinically stable The subject has a baseline FEV1 = 80% of predicted.
排除标准
- •As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
- •The subject has a history of allergy to excipients, MDI propellants, or a history of drug or other allergy that, in the opinion of the physician responsible makes the volunteer unfit to participate.
- •The subject has recently participated in another clinical trial.
- •The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 or 14 days.
- •The subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female, or an average daily intake of greater than 3 units regularly, where 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- •Any history of breathing problems (e.g. history of asthmatic symptoms).
- •The subject is infected with the hepatitis B, hepatitis C, or HIV virus.
- •The subject is has a positive drugs of abuse test.
- •The subject has had a respiratory tract infection within 4 weeks of the start of the study.
- •The subject has a past or present disease, which as judged by the Doctor, may affect the outcome of this study.
- •The subject has a history of life-threatening asthma.
- •The subject has taken inhaled, nasal or dermal steroids within 4 weeks or oral steroids within 8 weeks of the start of the study.
- •The subject has taken long acting inhaled beta 2 agonists within 96 hours before the screening visit.
- •The subject has taken short acting inhaled beta 2 agonists within 8 hours before the screening visit.
- •The subject is unable to abstain from other drugs that may interfere with the conduct of the study or its interpretation.
- •The subject has ongoing rhinitis that requires treatment.
研究组 & 干预措施
Subjects receiving treatment sequence 1: Part 1
Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.
干预措施: GSK615915A (Drug)
Subjects receiving treatment sequence 1: Part 1
Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 2: Part 1
Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.
干预措施: GSK615915A (Drug)
Subjects receiving treatment sequence 2: Part 1
Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 1: Part 2
Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.
干预措施: GSK615915A (Drug)
Subjects receiving treatment sequence 1: Part 2
Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 2: Part 2
Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.
干预措施: GSK615915A (Drug)
Subjects receiving treatment sequence 2: Part 2
Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.
干预措施: Placebo (Drug)
Subjects receiving GSK615915A: Part 3
Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms.
干预措施: GSK615915A (Drug)
Subjects receiving placebo: Part 3
Eligible subjects will receive placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG)
时间窗: Up to 18 weeks
次要结局
- Levels of GSK615915A and any breakdown products in the blood and urine.(Up to 18 weeks)