NCT02074553 - A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers | Crick

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Alectinib

AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (\*) hour per milliliter (ng\*hour/mL).