A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential
Condition: Healthy Volunteers
Intervention: GDC-0134 F09 Formulation; GDC-0134 F15 Formulation; GDC-0134 F16 Formulation
Intervention description: Participants will receive a single oral dose of GDC-0134 reference capsule F09.; Participants will receive a single oral dose of GDC-0134 prototype capsule F15.; Participants will receive a single oral dose of GDC-0134 prototype capsule F16.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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 conditions. The study is open to healthy female participants of non-childbearing
      potential.
    

Eligibility criteria:

        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