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

Healthy Volunteer Clinical Trial

Official title:
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

Clinical Trial Summary

This two-group study will investigate the effect of food (group 1) and esomeprazole (group 2) on the single oral dose pharmacokinetics of RO5424802 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 RO5424802 per period separated by at least 10 days. Each subject will receive single, oral doses RO5424802 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 RO5424802 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 RO5424802 will be given after ingestion of a standard meal.

In all groups, pharmacokinetics will be assessed in the 4 days following RO5424802 administration.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02023125
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Completed
Phase Phase 1
Start date January 2014
Completion date February 2014
View Details
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