Status:
COMPLETED
A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy Volunteers
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief Summary
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 condit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2019
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03807739
Start Date
February 1 2019
End Date
May 30 2019
Last Update
August 31 2020
Active Locations (2)
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1
Covance Research Unit - Daytona
Daytona Beach, Florida, United States, 32117
2
Covance Research Unit - Dallas
Dallas, Texas, United States, 75247