EUCTR2010-021156-26-Outside-EU/EEA进行中（未招募）不适用
A Phase 1, Randomized, Open-label, Single-Dose, Crossover, Relative Bioavailability, and Food-Effect Study of a Pediatric Chewable Tablet Formulation Relative to a 375-mg Core Tablet Formulation of Telaprevir in Healthy Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
- All
入选标准
- •1. Subjects must be able to read, understand, sign the ICF, abide by the study requirements (e.g., comply with schedule visits, treatment regimen, laboratory tests, and other study procedures), and willing to complete the study as planned
- •2. Subjects must be healthy males and/or females of non-childbearing potential aged 18 to 65 years, inclusive. Healthy is defined as having no clinically relevant abnormalities identified by a detailed medical history and full physical examination (including blood
- •pressure, pulse rate measurement, 12-lead ECGs, and clinical laboratory tests) at the Screening Visit. Non-childbearing potential is defined in Section 12.6.6.
- •3. Subjects with a body mass index (BMI) of 18 to 30 kg/m2 and weigh >50 kg at the Screening Visit. Only 3 subjects with a BMI greater than 29 kg/m2 will be enrolled in this 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 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects with a positive test result for any of the following infectious diseases:
- •hepatitis A infection (confirmed by hepatitis A antibody IgM), hepatitis B antigen (HBsAG), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus 1 and
- •2 antibodies (HIV 1 Ab or HIV 2 Ab)
- •2. Subjects with a history of any illness that, in the opinion of the investigator or the subject’s general practitioner, 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, a history of (1) relevant drug or food allergies; (2) cardiovascular or central nervous system disease; (3) clinically significant pathology (history or presence);
- •(4) mental disease; or (5) chronic skin disease.
- •3. Subjects with a history of febrile illness within 5 days prior to the first dose of study drug
- •4. Subjects with any condition that may possibly affect drug absorption (e.g., gastrectomy, cholecystectomy, or other gastrointestinal track surgery, except appendectomy)
- •5. Subjects with a positive urine screen result for drugs of abuse (Table 12-2)
- •6. Subjects with a history of regular alcohol consumption exceeding 7 drinks/week for female subjects of non-childbearing potential or 14 drinks/week for male subjects, where 1 drink = 5 ounces (150 mL) of wine, 12 ounces (360 mL) of beer, or 1.5 ounces (45 mL) of hard liquor within 6 months of the Screening Visit
- •7. Subjects treated with an investigational drug within 30 days (or as determined by the local requirements, whichever is longer) or 5 half-lives preceding the first dose of study drug
- •8. Subjects with 12-lead ECG demonstrating QTc >450 msec at the Screening Visit. If the QTc exceeds 450 msec, then the ECG should be repeated 2 more times and the average of the 3 QTc values should be used to determine the subject’s eligibility
- •9. Subjects who use prescription and/or nonprescription drugs within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
- •10. Subjects who use vitamins and/or dietary supplements within 7 days before the first dose of study drug. Herbal supplements must be discontinued 14 days prior to the first dose of study drug.
- •11. Hormone replacement therapy must be discontinued 28 days prior to the first dose of study drug. Depo-Provera must be discontinued at least 6 months prior to the first dose of study drug. As an exception, acetaminophen/paracetamol may be used at doses of
- •=1g/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 Vertex Pharmaceuticals Incorporated (Vertex).
- •12. Subjects who have made a blood donation of approximately 1 pint (500 mL) within 56 days prior to the first dose of study drug
- •13. Subjects who are unwilling or unable to comply with the Lifestyle Guidelines, as described in Section 10.3
- •14. Subjects who are an investigator, sub-investigator, research assistant, pharmacist, study coordinator, staff, or a relative of study personnel directly involved with the conduct of the study
- •15. Subjects who consume an average of more than five 8-ounce servings of coffee or other caffeinated beverage or seven 8-ounce servings of cola per day up to 72 hours before the first dose of study drug
- •16. Subjects who have a female partner who is pregnant, nursing, or planning to bec
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