NL-OMON34361已完成不适用
A single ascending dose study to assess the safety, tolerability and pharmacokinetics of RO5428029 in healthy male subjects - PP25327
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
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 subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of
- •any active or chronic disease following a detailed medical and surgical history, a complete physical examination
- •including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
- •2. Body mass index (BMI) between 18 and 30 kg/mE2, inclusive (Part A) and between 18 and 26 kg/mE2,
- •inclusive (Part B), and with a minimum weight of 50 kg.
- •3. Subjects and their partners of childbearing potential must use 2 methods of contraception, one of which must
- •be a barrier method for the duration of the study and for 70 days after the last dose.
- •4. Able to participate and willing to give written informed consent and to comply with the study restrictions.
排除标准
- •1. Positive test for drugs of abuse at screening or Day -2.
- •2. History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average
- •(1 standard drink = 10 grams of alcohol). Alcohol consumption will be prohibited during study confinement and
- •at least 48 hours before screening, before dosing, and before each scheduled visit.
- •3. History or symptoms of any significant disease including (but not limited to), neurological, psychiatric,
- •endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder.
- •4. History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma (e.g.,
- •skin basal or squamous cell carcinoma).
- •5. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab) or human immunodeficiency
- •virus antibody (HIV Ab) at screening.
- •6. Confirmed (based on the average of 3 semi-supine, resting blood pressure measurements, properly measured
- •with well-maintained equipment, at each of > 2 visits to the office or clinic) systolic blood pressure (SBP) greater
- •than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg.
- •7. Use of any medications (prescription or over-the-counter [OTC]), vitamin, mineral, herbal, and dietary
- •supplements within 21 days of study drug administration, or less than 5 half-lives (whichever is longer).
- •Exceptions are paracetamol (up to 4 g/day) and ibuprofen (up to 1g/day). Other exceptions will only be
- •made if the rationale is discussed and clearly documented between the Investigator and the Roche*s Clinical
- •Pharmacologist.
- •8. Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete
- •blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed
- •during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant
- •for healthy subjects.
- •9. Participation in an investigational drug or device study within 3 months prior to screening.
- •10. Donation of blood over 500 mL within three months prior to screening.
- •11. Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with,
- •the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject
- •in this study.
- •12. Smoker of more than 10 cigarettes per day prior to Screening or who use tobacco products equivalent to more
- •than 10 cigarettes per day.
- •13. Any of the following findings in the resting ECG.
- •a) QTcF> 450 or < 300 msec at screening or baseline visit;
- •b) Notable resting bradycardia (HR < 45 bpm) or tachycardia (HR > 100 bpm) at screening or baseline visit;
- •c) Personal or family history of congenital long QT syndrome or sudden death;
- •d) Screening or baseline ECG with QRS and/or T wave judged to be unfavorable for a consistently accurate QT
- •measurement (e.g., neuromuscular artifact that cannot be readily eliminated, arrhythmias, indistinct QRS onset,
- •low amplitude T wave, merged T- and U-waves, prominent U waves);
- •e) Evidence of atrial fibrillation, atrial flutter, complete branch block, Wolf-Parkinson-White Syndrome, or
- •cardiac pacemaker at screening or baseline visit.
- •14. Any confirmed significant allergic reactions (u
研究者
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