A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers
Condition: Healthy Volunteer
Intervention: Ro542-4802/F03 (Reference); Ro542-4802/F07 (Test); Ro542-4802/F08 (Test); Ro542-4802/F14 (Test)
Intervention description: Participants will receive Ro542-4802/F03 (containing 50% SLS) 600 mg capsules orally on Day 1.; Participants will receive Ro542-4802/F07 (containing 25% SLS) 600 mg capsules orally on Day 1.; Participants will receive Ro542-4802/F08 (containing 3% SLS) 600 mg capsules orally on Day 1.; Participants will receive Ro542-4802/F14 (containing 12.5% SLS) 600 mg capsules orally on Day 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This 2-part, single center, open-label, randomized, single-dose, 4-sequence, 4-period
      cross-over study will compare the bioequivalence of three test RO5424802 capsule formulations
      with the reference capsule formulation in healthy adult volunteers. All participants in both
      fasted (Part 1) and fed (Part 2) conditions of the study will receive each of 4 treatments
      (Ro542-4802/F03 [RO5424802 with 50 percentage (%) sodium lauryl sulfate (SLS) (reference)],
      Ro542-4802/F07 [RO5424802 with 25% SLS (test)], Ro542-4802/F14 [RO5424802 with 12.5% SLS
      (test)] and Ro542-4802/F08 [RO5424802 with 3% SLS (test)] in a randomized sequence. Each
      treatment will be given as a single 600 milligrams (mg) oral administration in an upright
      position on Day 1 after an overnight fast, followed by a 10-day washout period. Total time on
      study is expected to last up to 75 days, for each enrolled participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and surgically sterile or post-menopausal female participants 18-55 years
             of age

          -  Body mass index (BMI) between 18 to 32 kilograms per meter-squared (kg/m^2)

          -  Non-smoking participants and former smoking participants (who have not smoked for the
             past six months before first dosing)

          -  Male participants and their partners of child-bearing potential must be willing to use
             two effective contraceptive methods as defined by protocol

          -  Willing to abstain from xanthine-containing beverages and food (coffee, tea, cola,
             chocolate, and "energy drinks") from 72 hours prior to Day -1 through the study

          -  Willing to abstain from grapefruit, pomelo, star fruit or Seville orange containing
             products from day 7 prior study start until study end

          -  Willing to avoid prolonged sun exposure while taking RO5424802 and through follow-up

        Exclusion Criteria:

          -  Pregnant or lactating women, men with female partners who are pregnant or lactating,
             or women of child bearing potential

          -  Clinically significant abnormalities on physical examination, vital signs, or
             laboratory test results during screening or prior to admission to the study unit

          -  Positive test for drugs of abuse, alcohol or cotinine test at screening or prior to
             admission to the study unit or suspicion of regular consumption of drug(s) of abuse

          -  History of recent alcohol consumption exceeding 2 standard drinks per day on average.
             Alcohol consuming is prohibited from 72 hours prior to study start until the end of
             the study

          -  Participants with any risk factors or family history for QT/QTcF and electrocardiogram
             (ECG) abnormalities

          -  A history of any concurrent clinically significant hematologic, renal, hepatic,
             pulmonary, neurological, psychiatric, allergies, gastrointestinal, metabolic or
             endocrine disorder, or cardiovascular disease or infections

          -  Positive screening test for hepatitis B, C, or human immunodeficiency virus (HIV)

          -  Use of any medications (prescriptions or over-the-counter), within 2 weeks or 5
             half-lives (whichever is longer) before the first dose of study medication with
             exception of acetaminophen up to 2 grams (g) per day up to 48 hours prior to dosing,
             not to exceed 4 g total during the week prior to dosing

          -  Routine or chronic use of more than 2 g of acetaminophen daily

          -  Use of any herbal supplements (for example, St. John's Wort) or any metabolic inducers
             within 4 weeks or 5 half-lives (whichever is longer) before the first dose of study
             medication, including but not limited to the following drugs: rifampin, rifabutin,
             glucocorticoids, carbamazepine, phenytoin, and phenobarbital

          -  Strenuous activity, sunbathing or contact sports are not allowed from 4 days prior to
             study start until the end of the study

          -  Participation in an investigational drug or device study within 45 days or 5
             half-lives (whichever time period is longer), or 6 months for biologic therapies,
             prior to first dosing

          -  Donation of blood over 450 milliliters (mL) within 45 days prior to screening