A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants
Condition: Healthy Volunteer
Intervention: Cobimetinib; Rabeprazole
Intervention description: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast or approximately 30 minutes after starting the standardized FDA high-fat meal.; Rabeprazole 20 mg will be administered orally once daily for 4 days starting on Day -4 and on Day 1 of the treatment period.
Intervention MeSH terms: Rabeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover
      study of cobimetinib in healthy participants to evaluate the effect of the proton-pump
      inhibitor (PPI) rabeprazole on the relative bioavailability of cobimetinib in healthy
      participants when administered in the fed or fasted states.
    

Eligibility criteria:

        Inclusion Criteria

          -  With a body mass index range of 18.5 to 29.9 kilograms per meter square (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 (does not include alcohol) and
             at each Check-in

          -  Negative hepatitis panel (including hepatitis B virus surface antigen [HBsAg] and
             hepatitis C virus antibody [anti-HCV]) and negative human immunodeficiency virus (HIV)
             antibody screens

          -  Healthy males and females of nonchildbearing potential 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/or cholecystectomy will be allowed

          -  History or presence of an abnormal ECG

          -  History of alcoholism or drug addiction within 1 year prior to Period 1 Check-in

          -  Use of any tobacco- or nicotine-containing products within 6 months prior to Period 1
             Check-in

          -  Participation in any other investigational study drug trial in which receipt of an
             investigational study drug occurred within 30 days or 5 half-lives, whichever is
             longer, prior to Period 1 Check-in

          -  Use of any prescription medications/products within 14 days prior to Period 1 Check-in

          -  Use of any over-the-counter, non-prescription preparations within 7 days prior to
             Period 1 Check-in

          -  Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72
             hours prior to Period 1 Check-in

          -  Poor peripheral venous access

          -  Any acute or chronic condition that would limit the participant's ability to complete
             and/or participate in this clinical study

          -  Female participant is pregnant, lactating, or breastfeeding

          -  Use of PPIs or histamine H2 receptor antagonists within 1 month prior to Period 1
             Check-in

          -  Known hypersensitivity to rabeprazole or any of its components or to derived products
             of benzimidazoles

          -  Predisposing factors to retinal vein occlusion (RVO)