At a glance
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An Open-Label, Two-Group Study to Investigate the Effect of Food (Group 1) and Esomeprazole (Group 2) on the Single Oral Dose Pharmacokinetics of RO5424802 in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Alectinib, Esomeprazole, and 2 other interventions for Healthy Volunteer. Completed, enrolled 42 participants across 1 site.
Detailed Summary
This two-group study will investigate the effect of food (Group 1) and esomeprazole (Group 2) on the single oral dose pharmacokinetics of alectinib in healthy volunteers. Participants in Group 1 will be randomly assigned to a two period treatment sequence (AB or BA) in which they will receive a single, oral dose of alectinib per period separated by at least 10 days. Each participant will receive single, oral doses alectinib given under fasted conditions (Treatment A) or following the ingestion of a high fat, high calorie meal (Treatment B) as determined by their assigned sequence. Participants in Group 2 will be given a single, oral dose of alectinib following a standard meal. After a washout period of at least 10 days, they will receive an oral dose of esomeprazole (40 mg) once daily for 6 days. On the 6th day of esomeprazole administration, a single, oral dose alectinib will be given after ingestion of a standard meal. In all groups, pharmacokinetics will be assessed in the 4 days following alectinib administration.
Study Details
Timeline
Interventions
A single 600-mg oral dose of alectinib will be administered in a fasted or fed condition.
Esomeprazole 40 mg will be administered orally once daily for 6 days prior to alectinib administration.
High fat and calorie meal served prior to alectinib administration
Standard meal served prior to alectinib administration