ISRCTN10450075
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Genentech, Inc.
- Enrollment
- 18
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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