A study to measure how much of the study drug GDC-6036 is absorbed and the effect of food on absorption in healthy participants
- Conditions
- Bioavailability and food effect of GDC-6036 in healthy subjectsNot Applicable
- Registration Number
- ISRCTN10450075
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 18
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method