Overview

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:

Participant gender:

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

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Polystyrene sulfonic acid