NCT00540878已完成1 期
An Open-Label, Randomized, Five Period Crossover Study to Estimate the Relative Bioavailability of Five Formulations of 400mg SB-751689 (a Calcium-Sensing Receptor Antagonist) Administered as a Single Oral Dose to Healthy Postmenopausal Females
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- AUC and CMAX after a single dose.
研究概览
简要总结
This study will examine the effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a single oral dose of each formulation, with five formulations of SB-751689 tested in total. Blood samples will be taken up to 24 hours postdose after each dose administration. This study will provide information for future possible formulation development of SB-751689 for Phase III.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy postmenopausal women; 40 and 65 years of age, inclusive
- •Non-smokers (as defined in
排除标准
- •Body weight > or = 50 kg and BMI within the range 19-32 kg/m2
- •Capable of giving written informed consent and complying with the requirements and restrictions listed in the consent form
- •Exclusion criteria:
- •Any clinically relevant biological or physical abnormality found or reported at screening which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study
- •A QTc interval of > 450 msec at screening
- •Positive urine drug screen at screening
- •Positive urine test for alcohol at pre-dose
- •Positive for HIV or hepatitis B or C virus at screening
- •Urinary cotinine levels indicative of smoking at screening
- •History of smoking or use of nicotine containing products within one year of the study or >10 pack-year history of smoking overall
- •History of regular alcohol consumption exceeding 7 units/week (1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening
- •History of drug abuse within 6 months of the study
- •Participation in a clinical study and received a drug or a new chemical entity with 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of the current study medication.
- •Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- •Use of prescription or non-prescription drugs
- •Consumption of red wine, grapefruit, grapefruit juice or grapefruit containing products within 14 days prior to the first dose of study medication
- •Donation of blood in excess of 500 mL within 56 days prior to dosing
- •Evidence of renal, hepatic or biliary impairment
- •History of serious gastrointestinal disease
- •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 physician responsible, contraindicates their participation.
- •History of clinically significant cardiovascular disease
- •Medical conditions that might alter bone metabolism
- •Serum parathyroid hormone (iPTH) test levels outside the reference range at screening
- •Liver function tests, parathyroid hormone test or CPK outside the reference range at screening
结局指标
主要结局
AUC and CMAX after a single dose.
时间窗: after a single dose
次要结局
- Safety and tolerability after single dose.(after a single dose)
研究者
研究点 (1)
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