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)

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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.


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
We found this trial at
2
sites
1341 West Mockingbird Lane
Dallas, Texas 75247
1220
mi
from 91732
Dallas, TX
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1900 Mason Avenue
Daytona Beach, Florida 32117
2186
mi
from 91732
Daytona Beach, FL
Click here to add this to my saved trials