ISRCTN32485300已完成不适用
A randomised, placebo-controlled, double-blind phase I study to assess the safety, tolerability and pharmacokinetics of repeated p. o. doses of 75 to 600 mg Priaculin in healthy male volunteers
Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 个研究点目标入组 32 人开始时间: 2010年6月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •2. Caucasian
- •3. Age 30 - 55 years (included)
- •4. BMI between 18 and 26 kg/m2
- •5. Healthy on the basis of extensive pre-study investigation
- •6. Willing and able to provide written informed consent
排除标准
- •1. Previous participation in the present trial
- •2. Participation in any other trial during the last 90 days
- •3. Donation of blood or plasma within the last 90 days before recruitment
- •4. History of any clinically relevant allergy
- •5. Presence of acute or chronic infection
- •6. Subjects with history or present conditions of clinically relevant cardiovascular, urogenital, gastrointestinal, hepatic, metabolic, endocrine, neurological or psychiatric abnormalities, defined in the clinical trial protocol
- •7. Presence or history of regular/habitual diarrhoea or constipation
- •8. Resting supine systolic blood pressure (SBP) > 140 or < 100 mmHg, resting supine diastolic blood pressure (DBP) > 95 or < 60 mmHg
- •9. Resting pulse (PR) or electrocardiographic heart rate (HR) < 50 bpm or > 100 bpm
- •10. Drop in SBP upon one minute relaxed upright standing (orthostatic challenge) by > 25 mmHg, or symptoms of faintness or dizziness on standing irrespective of the extent of standing blood pressure reduction
- •11. ECG-abnormalities: AV-block (AV-block grade I included), QT-interval >= 480 msec, QTc-interval (Bazett) >= 450 msec, sick-sinus syndrome
- •12. Subjects with relevant abnormalities in the clinical laboratory tests, defined in the clinical trial protocol
- •13. History of alcohol or (social) drug abuse
- •14. Positive alcohol or urine drug test
- •15. Daily consumption of > 30 g alcohol
- •16. Smoking more than 10 cigarettes/day or equivalent of other tobacco products or having done so within the last 6 months prior to inclusion into the study
- •17. Use of confounding medication
- •18. Suspicion or evidence that the subject is not reliable
- •19. Suspicion or evidence that the subject is not able to make a free consent or to understand the information detailed in the subject information sheet
研究者
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