ISRCTN10450075已完成1 期
A Phase I, open-label, single-dose, randomized, three-period crossover study to evaluate the relative bioavailability and food effect of GDC-6036 in healthy subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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
入排标准
- 性别
- All
入选标准
- •1. Males or females of non-childbearing potential, between 18 and 60 years of age, inclusive
- •2. Within body mass index (BMI) range 18.0 to 32.0 kg/m², inclusive
- •3. In good health, determined by no clinically significant findings from medical history, physical examination, triplicate 12-lead ECGs, and vital signs
- •4. Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (Day -1 of Period 1) (does include alcohol)
- •5. Negative hepatitis panel (hepatitis B surface antigen, hepatitis B virus core antibody, and hepatitis C virus antibody) and negative HIV antibody screens
- •6. Able and willing to consume 100% of a high-fat breakfast meal (two eggs fried in butter, two strips of bacon, two slices of toast with butter, 4 ounces of hash brown potatoes, and 8 ounces of whole milk)
- •7. Receive an explanation of the mandatory whole genome sequencing component of the study
排除标准
- •1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator)
- •2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
- •3. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and hernia repair will be allowed
- •4. History or presence of an abnormal ECG, which, in the Investigator’s opinion, is clinically significant
- •5. Have a QTc interval corrected for heart rate using Fridericia’s formula >450 msec for males, >470 msec for females, PR interval >210 msec, or QRS complex >120 msec. Triplicate ECGs will be performed at Screening and at Check-in and the mean value of the 3 measurements will be used. If intervals are out of range, ECGs may be repeated once at Screening and once at Check-in, and the average of the intervals will be used to determine eligibility
- •6. History of alcoholism or drug addiction within 1 year prior to Check-in (Day -1 of Period 1)
- •7. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer
- •8. Receipt of a coronavirus disease 2019 (COVID-19) vaccine in the past 28 days prior to dosing
- •9. Use of any prescription medications/products within 14 days prior to Check-in (Day -1 of Period 1), unless deemed acceptable by the Investigator
- •10. Use of any over-the-counter, non-prescription preparations (including vitamins; minerals; and phytotherapeutic-, herbal-, and plant-derived preparations) within 7 days prior to Check-in (Day -1 of Period 1), unless deemed acceptable by the Investigator
- •11. Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 3 months prior to Check-in (Day -1 of Period 1) and during the entire study
- •12. Use of poppy seed-, grapefruit-, star fruit-, pomegranate-, pawpaw-, or Seville orange-containing foods or beverages within 7 days prior to Check-in (Day -1 of Period 1) and until completion of Period 3, unless deemed acceptable by the Investigator
- •13. Use of alcohol-containing foods or beverages within 48 hours prior to Check-in (Day -1 of Period 1) and until completion of Period 3
- •14. Use of caffeine-containing foods or beverages within 48 hours prior to Check-in (Day -1 of Period 1) and until completion of Period 3, unless deemed acceptable by the Investigator
- •15. Participation in strenuous exercise from 48 hours prior to Check-in (Day -1 of Period 1) and during the period of confinement at the study site (e.g., will not begin a new exercise program or participate in any unusually strenuous physical exertion)
- •16. Poor peripheral venous access
- •17. History of malignancy, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
研究者
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