NCT00857467已完成1 期
Randomised, Double-blind, Single Dose, Three-way, Cross-over Study to Investigate the Safety and Response to 1g or 2g Rectal Suppositories Containing 5 mg or 10 mg 1R,2S-methoxamine Hydrochloride [NRL001] or Matching Placebo
Norgine1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in MARP after a single dose
研究概览
简要总结
This is a healthy volunteer three-way crossover study. A total of 12 subjects will receive three single administrations of 1 g rectal suppositories (containing either 5 mg NRL001, 10 mg NRL001 or matching placebo), with a washout period of at least 7 days between dosings. A further 12 subjects will receive three single administrations of 2 g rectal suppositories (containing either 5 mg NRL001, 10 mg NRL001 or matching placebo), again with a 7 day washout period between dosings. The pharmacodynamic response, pharmacokinetics and safety profile will be determined.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •No previous history of ano-rectal conditions or diseases
- •No history of cardiovascular disease
- •18 to 60 years of age
- •Males and females (pre-menopausal females of child-bearing potential must be using adequate contraceptive methods and have a negative pregnancy test before the start of the study)
排除标准
- •Use of medication in the last 30 days with a vasodilatory activity, or use of any medication currently or within the last 30 days which the Investigator believes may affect the study participation or results
- •Use of monoamine oxidase inhibitors presently or within the last 2 weeks before study participation
- •Use of any medication in the last 30 days applied to the anus and/or via the rectum
- •Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last three months which involved being paid a disturbance allowance; having an invasive procedure (e.g. venepuncture >50ml, endoscopy) or exposure to ionising radiation.
- •Regular intake of more than 21 units of alcohol per week
- •History or any evidence of cardiovascular disease including ischaemic heart disease and hypertension (defined on examination: systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 90 mmHg; based on at least two separate readings), peripheral vascular disease or Raynaud's syndrome
- •Presence of diabetes mellitus
- •History or symptoms of thyroid diseases, including hypo- or hyperthyroidism
- •Pregnant or lactating females
- •History of any clinically relevant allergy
- •Presence of concomitant gastrointestinal diseases or disorders, such as significant abdominal symptoms and haemorrhoids but also any significant organ (e.g. renal, hepatic or cardiac) dysfunction
- •Volunteers whom the Investigator feels would not comply with the requirements of the trial
- •Volunteers who have been exposed to more than 5 mSv of ionising radiation in the last 12 months.
研究组 & 干预措施
1 g suppository
Experimental
Subjects receive 5 mg NRL001, 10 mg NRL001 and placebo in a 1g rectal suppository
干预措施: NRL001 (Drug)
2 g suppository
Experimental
Subjects receive 5 mg NRL001, 10 mg NRL001 and placebo in a 2 g rectal suppository.
干预措施: NRL001 (Drug)
结局指标
主要结局
Change in MARP after a single dose
时间窗: 6 hours
次要结局
- Pharmacokinetic plasma assessment to determine systemic uptake(6 hours)
- Adverse events(6 hours)
- Cardiovascular parameters; heart rate and blood pressure(6 hours)
研究者
研究点 (1)
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