A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label study will investigate whether multiple oral doses of posaconazole affect the single dose pharmacokinetics of alectinib in healthy volunteers.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Posaconazole

Criteria

Inclusion Criteria:

• Body mass index (BMI) between 18 to 32 kilogram per square meter (kg/m^2)

• Male volunteers must use effective contraception as outlined in the protocol

• Willingness to abstain from alcohol and xanthine-containing beverages or food (coffee, tea, cola, chocolate and "energy drinks") from 72 hours prior to the first dose until discharged

• Willingness to avoid prolonged sun exposure and guard against sunburn during study and follow-up

Exclusion Criteria:

• Clinically significant medical history or findings in physical examination, vital signs, or laboratory test results prior to study start

• Positive screening tests for hepatitis B or C, human immunodeficiency virus (HIV), alcohol, drugs of abuse, or tobacco

• Women of childbearing potential, or males with pregnant or lactating partners

• Regular smoking within 6 months prior to first dosing. Participants should avoid smoky environments for at least 1 week prior to each cotinine screen

• Excessive alcohol consumption

• Use of any metabolic inducers (including herbals such as St. John's Wort) within 4 weeks or 5 half-lives (whichever is longer) before the first dose of study medication, including but not limited to: rifampin, rifabutin, glucocorticoids, carbamazepine, phenytoin and phenobarbital

• Strenuous activity, sunbathing, or contact sports are not allowed from 4 days prior to entry into the clinical site until study follow-up

• Participation in an investigational drug or device study within 45 days (or 6 months for biologic therapies) prior to first dosing