A Study to Evaluate Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Participants
Condition: Healthy Participants
Intervention: Cobimetinib; Itraconazole
Intervention description: 10 milligram (mg) (2* 5 mg capsules) will be administered orally on Day 1 of Period 1 and Day 4 of Period 2; 200 mg oral solution will be administered once daily from Day 1 to Day 14 of Period 2
Intervention MeSH terms: Itraconazole
Phase: Phase 1
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This open-label, 2-period, fixed sequence, drug interaction study will investigate the effect
      of co-administration of itraconazole on the pharmacokinetics of cobimetinib in healthy
      participants. Participants will receive multiple repeating doses of cobimetinib and
      itraconazole.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult participants

          -  Within body mass index (BMI) range 18.5 to 32 kilogram per meter square (kg/m^2),
             inclusive

          -  Creatine phosphokinase levels below 2.5 times the upper limit of normal (ULN) and if
             elevated, not clinically significant

          -  Liver function tests for aspartate aminotransferase, alanine aminotransferase, and
             alkaline phosphatase below 2 times the ULN; bilirubin below 1.5 times the ULN; and all
             liver function test elevations not clinically significant

          -  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,
             unless deemed not clinically significant by the Investigator

          -  Negative test for selected drugs of abuse at screening and at each check-in

          -  Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and
             anti-hepatitis C virus [HCV]) and negative human immunodeficiency virus (HIV) antibody
             screens

          -  Females non-pregnant or non-lactating

          -  Males and females (of child-bearing potential) to use two forms of adequate
             contraception

        Exclusion Criteria:

          -  Significant history or clinical manifestation of any 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, unless approved by the Investigator

          -  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 of diabetes mellitus and/or elevated fasting glucose at baseline

          -  History or presence of an abnormal ECG, which in the Investigator's opinion, is
             clinically significant

          -  History of alcoholism or drug addiction within 1 year prior to study start

          -  Use of any tobacco- or nicotine-containing products (within 6 months prior to study
             start and during the entire study

          -  Participation in any other investigational study or biologic agent trial in which
             receipt of an investigational study drug occurred within 5 half-lives or 30 days,
             whichever is longer, or exposure to any biological therapy or investigational
             biological agent within 90 days prior to study entry and during the entire study from
             study start to study completion, inclusive