A Study Examining the Bioequivalence of 3 Alectinib (RO5424802) Test Formulations to a Reference Formulation of in Healthy Participants

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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 alectinib capsule formulations with the reference capsule formulation in healthy adult participants. All participants in both fasted (Part 1) and fed (Part 2) conditions of the study will receive each of 4 treatments: Treatment A (alectinib with 50 percent [%] sodium lauryl sulfate [SLS] [reference]), Treatment B (alectinib with 25% SLS [test]), Treatment C (alectinib with 12.5% SLS [test]), and Treatment D (alectinib 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 in a fed or fasted condition, followed by a 10-day washout period.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Polystyrene sulfonic acid

Criteria

Inclusion Criteria:

• Healthy male and female participants. Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, and a complete physical examination

• Body mass index between 18 to 32 kilograms per meter-squared (kg/m^2) inclusive

• Non-smoking participants and former smoking participants who have not smoked for the past 6 months before first study drug dosing

• Female participants must be surgically sterile or postmenopausal for the past year

• Male participants and their partners of childbearing potential must be willing to use two effective methods of contraception, one of which must be a barrier method (for example, condom) during the study and for 90 days after the last drug administration

• Willing to abstain from xanthine-containing beverages and food (coffee, tea, cola, chocolate, and "energy drinks") from 72 hours prior to Day -1 through study end

• 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 alectinib and through follow-up

Exclusion Criteria:

• Women of childbearing potential, pregnant or lactating women, or males with female partners who are pregnant or lactating

• Clinically significant abnormalities on physical examination, vital signs, or laboratory test results during screening or prior to admission to the study center

• Positive test for drugs of abuse, alcohol, or cotinine at screening or prior to admission to the study center or suspicion of regular consumption of drug(s) of abuse including marijuana

• History (within 3 months of Screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams [g] of alcohol). Alcohol consuming will be prohibited from 72 hours prior to study start until the end of the study

• Participants with any risk factors or family history for QT/Fridericia's corrected QT interval (QTcF) prolongation or electrocardiogram 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 drug with exception of acetaminophen up to 2 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 drug, 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 study drug dosing

• Donation of blood over 450 milliliters within 45 days prior to screening