EUCTR2007-005695-14-GB进行中（未招募）不适用
A Double-Blind, Placebo-Controlled, Randomized, Single-Dose, 2-Period Crossover Study of the Pharmacodynamics of Orally Administered PSI-697 in Healthy Subjects Who Smoke
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development0 个研究点目标入组 30 人开始时间: 2007年11月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Signed and dated an institutional review board (IRB)/independent ethics committee (IEC)-approved informed consent form before any study-specific screening procedures are performed.
- •2. Men, aged 18 to 55 years inclusive at screening. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration.
- •3. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight =50 kg.
- •BMI is calculated by taking the subject’s weight, in kilograms, divided by the square of the subject’s average height, in meters, at screening:
- •BMI = weight (kg)/[height (m)]2
- •4. Healthy as determined by the investigator on the basis of medical history,
- •physical examination, clinical laboratory test results, vital signs, and 12-lead
- •electrocardiogram (ECG).
- •5. Smoker of at least 1 pack or more of cigarettes per day (20 +/- 3 cigarettes) for
- •> 1 year as determined by history.
- •6. Have a high probability for compliance with and completion of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical History
- •1. Presence or history of any disorder that may prevent the successful completion
- •of the study.
- •2. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
- •endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric
- •3. Any diagnosed bleeding disorder.
- •4. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
- •5. Any major surgical procedure within 6 months before study day 1.
- •6. Any history of major bleeding (eg, bleeding peptic ulcer) within 1 year before
- •study day 1.
- •7. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days
- •before study day 1.
- •8. History of drug abuse within 1 year before study day 1.
- •9. History of alcoholism within 1 year of day 1, admitted alcohol abuse, or consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%]
- •wine = 12 g; 4 cL glass of aperitif; 42° [42%] whiskey = 17 g; 25 cL glass of 3°
- •[3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g).
- •Physical and Laboratory Findings
- •10. Any clinically important deviation from normal limits in physical examination,
- •vital signs, 12-lead ECGs, or clinical laboratory test results.
- •11. Positive findings of urine drug screen (eg, amphetamines, barbiturates,
- •benzodiazepines, cannabinoids, cocaine, opiates, and phencyclidine [PCP]).
- •12. Positive serologic findings for human immunodeficiency virus antibodies, hepatitis B surface antigen, and/or hepatitis C virus antibodies.
- •Allergies and Adverse Drug Reactions
- •13. History of any clinically important drug allergy or adverse drug reaction.
- •Prohibited Treatments
- •14. Use of any investigational or prescription drug within 30 days before test article
- •administration.
- •15. Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or
- •soda) or alcoholic beverages within 24 hours before study day 1 (period 1 and 2).
- •16. Consumption of grapefruit or grapefruit-containing products within 72 hours
- •before study day 1 (period 1 and 2).
- •17. Use of any over-the-counter drugs, including herbal supplements (except for the
- •occasional use of paracetamol and vitamins =100% of the recommended daily
- •allowance) within 14 days before study day 1 (period 1).
- •18. Donation of blood within 90 days before study day 1.
- •19. Total annual amount of compensation earned from participating in clinical trials
- •exceeding 3200 stirling pounds
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