An Absolute Bioavailability Study in Healthy Participants Comparing Oral to Intravenous Administration of GDC-0973 (Cobimetinib)
Condition: Healthy Volunteers
Intervention: GDC-0973 IV Infusion; GDC-0973 Oral Capsules
Intervention description: IV infusion.; Oral dose.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of Part 1 of this study is to evaluate the safety and tolerability of
      the intravenous (IV) dose of GDC-0973. The primary objectives of Part 2 of this study are to
      evaluate the absolute bioavailability of GDC-0973 and to evaluate the pharmacokinetic (PK) of
      GDC-0973 following IV and oral administration. The secondary objective of Part 2 of this
      study is to evaluate the safety of GDC-0973 administered orally and intravenously.
    

Eligibility criteria:

        Inclusion Criteria

          -  Within body mass index range 18.5 to 29.9 kilograms per square meter (kg/m^2)

          -  In good health, determined by no clinically significant findings from medical history,
             12-lead electrocardiogram (ECG), and vital signs

          -  Clinical laboratory evaluations within the reference range for the test laboratory

          -  Negative test for selected drugs of abuse at Screening and at each Check-in

          -  Negative hepatitis panel and anti-hepatitis C virus and negative human
             immunodeficiency virus (HIV) antibody screens

          -  Healthy males and females of non-child-bearing potential or who agree to use effective
             contraception

        Exclusion Criteria

          -  Significant history or clinical manifestation of any significant metabolic, allergic,
             dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,
             gastrointestinal, neurological, or psychiatric disorder

          -  History of significant hypersensitivity, intolerance, or allergy to any drug compound,
             food, or other substance

          -  History of stomach or intestinal surgery or resection that would potentially alter
             absorption and/or excretion of orally administered drugs except that appendectomy,
             hernia repair, and cholecystectomy will be allowed

          -  History or presence of an abnormal ECG

          -  History of alcoholism or drug addiction prior to period 1 check-in

          -  Use of any tobacco-containing or nicotine-containing products prior to period 1
             check-in

          -  Participation in any other investigational study drug trial in which receipt of an
             investigational study drug occurred within 28 days or 5 half-lives, whichever is
             longer, prior to period 1 check-in

          -  Use of any prescription medications/products, including proton pump inhibitors, within
             14 days prior to period 1 check-in

          -  Poor peripheral venous access

          -  Any acute or chronic condition that would limit the participants ability to complete
             and/or participate in this clinical study

          -  Female participant is pregnant, lactating, or breastfeeding

          -  Predisposing factors to retinal vein occlusion (RVO)