A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers.

PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
Healthy Volunteer
Interventions
DRUG

Alectinib

A single 600-mg oral dose of alectinib will be administered in a fasted or fed condition.

DRUG

Esomeprazole

Esomeprazole 40 mg will be administered orally once daily for 6 days prior to alectinib administration.

OTHER

High Fat and Calorie Meal

High fat and calorie meal served prior to alectinib administration

OTHER

Standard Meal

Standard meal served prior to alectinib administration

Trial Locations (1)

78744

Austin

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02023125 - A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers. | Biotech Hunter | Biotech Hunter