Clareo Health | A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–65
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Body mass index (BMI) range 18.5 to 35 kilograms per square meter (kg/m2)
In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs;
Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the principal investigators (PIs)
Females of non-childbearing potential only
You may not be if
History or clinical manifestation of any significant medical condition as determined by the PI (or designee)
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the PI (or designee)
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
Use of any prescription medications/products within 14 days prior to Check-in (Day -1) for their first treatment period and during the entire study duration, unless deemed acceptable by the PI
Use of oral antibiotics within 4 weeks or intravenous antibiotics within 8 weeks prior to the Screening evaluation and during the entire study duration
Use of any over-the-counter, non-prescription preparations within 14 days prior to Check-in (Day -1) for their first treatment period and during the entire study duration, unless deemed acceptable by the PI
Use of acid reducing medications (proton pump inhibitors \[PPIs\], histamine H2-receptor antagonists \[H2RAs\]) within 14 days prior to Check-in (Day -1) for their first treatment period and during the entire study duration. As an alternative, antacids may be allowed at least 4 hours before or after dose
Use of any vaccines (including seasonal flu and H1N1 vaccines) within 14 days prior to Check-in (Day -1) for their first treatment period
Use of tobacco- or nicotine-containing products within 6 months prior to Check-in (Day -1) for their first treatment period and during the entire study
Any acute or chronic condition or any other reason that, in the opinion of the PI, would limit the subject's ability to complete and/or participate in this clinical study
