NL-OMON40275已完成不适用
A phase 1, double blind (3rd party open), randomized, placebo controlled, crossover single dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06372865 in healthy subjects - A study to investigate the effects of PF-0637286 in healthy volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 45
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests).;Female subjects of non-childbearing potential must meet at least one of the following criteria:
- •a. Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum FSH level within the laboratory*s reference range for postmenopausal females.
- •b. Have undergone a documented hysterectomy and/or bilateral oophorectomy.
- •c. Have medically confirmed ovarian failure.;All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.;2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).;3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.;4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •1. Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).;2. Subjects with history of sleep apnea.;3. Any condition possibly affecting drug absorption (eg, gastrectomy).;4. A positive urine drug screen.;5. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.;6. Treatment with another investigational drug within 3 months prior to screening or having participated in more than 4 investigational drug studies within 1 year prior to screening.;7. Screening supine blood pressure >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject*s eligibility.;8. 12-lead ECG demonstrating QTcF >450 msec or a QRS interval >120 msec at Screening. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject*s eligibility.;9. Males who are unwilling or unable to use a highly effective method of contraception
- •as outlined in this protocol for the duration of the study and for at least 90 days after
- •the last dose of investigational product.;10. Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug. As an exception, acetaminophen/paracetamol may be used at doses of =<1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.;11. Herbal supplements and hormone replacement therapy within 28 days prior to the first dose of study drug.;12. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.;13. Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.;14. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.;15. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
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