NL-OMON46528已完成不适用
A Phase 1, Randomized, Double-blind, Placebo controlled, Crossover Study to Evaluate the Pharmacodynamic Effects of VX*150 in Healthy Male Adults - PD study in healthy adults using VX-150
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
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.Subject will sign and date an informed consent form (ICF).
- •2.Willing and able to comply with scheduled visits, treatment plan, study restrictions laboratory tests, contraceptive
- •guidelines, and other study procedures.
- •3. Male subjects will be between the ages of 18 and 55 years, inclusive, and healthy, as defined by no clinically relevant abnormalities identified by a detailed medical history, physical examination (PE) of all body systems, including blood pressure and pulse rate measurement, standard 12 lead ECG, and clinical laboratory tests.
- •4. Body mass index (BMI) of 18.0 to 38.0 kg/m2, inclusive, and a total body weight >50 kg.
排除标准
- •1.History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of
- •the study or pose an additional risk in administering study drug to the subject. This may include, but is not limited
- •to, history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; history or
- •presence of clinically significant pathology; clinically significant history of mental disease; and history of cancer,
- •except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ (all 3 with no recurrence for the last 5 years).
- •2.History of febrile illness within 5 days before the first study drug dose.
- •3.A screen positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or antibodies against human immunodeficiency viruses 1 and 2 (HIV 1/HIV 2 Abs).
- •4.Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy, or other gastrointestinal tract surgery, except appendectomy).
- •5.Standard 12 lead ECG demonstrating QTcF >450 msec at screening. If QTcF exceeds 450 msec, the ECG will be repeated 2 more times, and the average of the 3 QTcF values will be used to determine the subject*s eligibility.
- •6.History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s); or history or evidence of abnormal ECGs that, in the opinion of the investigator or medical monitor, would preclude the subject*s participation in the study.
- •7.Male subjects with a female partner who is planning to become pregnant during the study or within 90 days after the last study drug dose.
- •8.Blood donation (of approximately 1 pint [500 mL] or more) or any significant loss of blood within 90 days before the first study drug dose, as determined by the investigator.
- •9.Use of restricted medication or food within the specified duration before the first dose of study drug, as defined in Table 9 1.
- •10.Enrollment in a previous cohort or part in this study.
- •11.History of regular alcohol consumption exceeding 21 drinks per week within 6 months before screening (1 drink equals 5 ounces/150 mL of wine, 12 ounces/360 mL of beer, or 1.5 ounces/45 mL of hard liquor)
- •12.A positive test for alcohol.
- •13.A history of drug abuse or dependence (according to DSM-IV criteria) within 2 years before the first dose of study drug or a screen positive for drugs of abuse as defined in Section 11.6.2.
- •14.Subject, or close relative of the subject, is the investigator or a subinvestigator, research assistant, pharmacist, study coordinator, or other staff directly involved with the conduct of the study at that site.
- •15.Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold (such as atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism) or pain (i.e., disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, neuropathy)
- •16.Subjects indicating pain tests intolerable at screening or achieving tolerance at > 80% of maximum input intensity for any pain test for cold, pressure and electrical tests.
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