NCT00731250已完成1 期
A Randomised, Double-blind, Placebo-controlled Study to Assess the Effect of Oral, Single Dose SB-705498 in a Validated Intranasal Capsaicin Challenge Model in Healthy Volunteers
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
- 45
- 试验地点
- 1
- 主要终点
- Symptom scores and secretion weights
研究概览
简要总结
This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Male or female between 18 and 60 years of age inclusive.
- •Non-child bearing women or women of child bearing potential if they agree to use contraception as indicated by the protocol
- •Non-smoker for at least 6 months with a pack history <5 pack years (Pack years = (No. of cigarettes smoked/day/20) x No. of years smoked).
- •Body weight > 50 kg and body mass index (BMI) within the range 19 - 29.9 kg/m2 (inclusive).
- •Capable of giving written informed consent.
- •Available to complete all the required study measurements.
- •Normal 12-lead ECG at screening.
- •For Part 2 only: The subject must demonstrate reactivity to unilateral, intranasal challenge with the selected single dose of capsaicin, defined as development of TSS ≥ 3.
排除标准
- •Past medical history of rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis.
- •Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations.
- •A history of gastrointestinal, hepatic, renal or multiple cardiovascular risk factors.
- •Positive pre-study drug/alcohol screen.
- •Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- •A positive test for human immunodeficiency virus (HIV) antibody (if determined by the local standard operating procedures (SOPs)).
- •History of regular alcohol consumption within 6 months of the study.
- •Exposure to more than four new chemical entities within 12 months prior to the start of the study.
- •Participation in a clinical trial with a new molecule entity or any other clinical trial within 4 months of the start of the study.
- •Use of prescription or non-prescription drugs, as well as of vitamins, herbal and dietary supplements (including St John's Wort) within 2 days prior to each study visit in Part 1 of the study or 14 days prior to the first treatment administration in Part 2 of the study.
- •Inability to abstain from all intranasal or oral medication to treat nasal symptoms from the first capsaicin challenge to the completion of the study including: sodium cromoglycate, antihistamines, anticholinergics, alpha-adrenergic agonists and corticosteroids
- •History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.
- •Subjects demonstrating hypersensitivity to the placebo capsaicin challenge at baseline screening.
- •Donation of blood or blood products in excess of 500mL within a 56 day period prior the start of Part 2 of this study.
- •Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.
- •Lactating females.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •Nicotine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- •For Part 2 only: Subjects with known lactose intolerance.
研究组 & 干预措施
PART 1-Visit 3-Placebo
Placebo Comparator
Eligible subjects will receive matching placebo tablets
干预措施: Placebo (Drug)
PART 1-Visit 1-Placebo
Placebo Comparator
Eligible subjects will receive matching placebo tablets
干预措施: Placebo (Drug)
PART 1-Visit 1-Capsaicin
Experimental
Eligible subjects will receive incremental capsaicin doses
干预措施: Caspaicin (Other)
PART 1-Visit 2-Placebo
Placebo Comparator
Eligible subjects will receive matching placebo tablets
干预措施: Placebo (Drug)
PART 1-Visit 2-Capsaicin
Experimental
Eligible subjects will receive maximum capsaicin dose
干预措施: Caspaicin (Other)
PART 1-Visit 3-Capsaicin
Experimental
Eligible subjects will receive matching placebo tablets incremental capsaicin doses
干预措施: Caspaicin (Other)
PART 2-Visit 1-Placebo
Placebo Comparator
Eligible subjects will receive matching placebo tablets
干预措施: Placebo (Drug)
PART 2-Visit 1-SB-705498
Experimental
Eligible subjects will receive SB-705498 tablets
干预措施: SB-705498 (Drug)
PART 2-Visit 2-Capsaicin
Experimental
Eligible subjects will receive matching placebo tablets incremental capsaicin doses
干预措施: Caspaicin (Other)
结局指标
主要结局
Symptom scores and secretion weights
时间窗: up to 83 days
次要结局
- Peak nasal inspiratory flow changes after challenge(up to 83 days)
- Biomarkers levels in the nasal samples(up to 83 days)
- Blood levels of drug(up to 83 days)
- Pharmacodynamic response(up to 83 days)
- Safety parameters(up to 83 days)
研究者
研究点 (1)
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