A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential
Status: | Recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 3/15/2019 |
Start Date: | March 28, 2019 |
End Date: | April 9, 2019 |
Contact: | Reference Study ID Number: GP40957 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6728 (U.S. Only) |
A Phase I Study to Determine the Relative Bioavailability of Various Formulations of GDC-0134 in Healthy Female Subjects of Non-Childbearing Potential
This is a two-part study to determine the relative bioavailability of two different prototype
capsules of GDC-0134 to that of an existing reference capsule of GDC-0134 under both fed and
fasted conditions. The study is open to healthy female participants of non-childbearing
potential.
capsules of GDC-0134 to that of an existing reference capsule of GDC-0134 under both fed and
fasted conditions. The study is open to healthy female participants of non-childbearing
potential.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
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