A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: danoprevir; Drug: omeprazole; Drug: ritonavir; Drug: ranitidine

• Registration Number: NCT01392755
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This randomized, open-label study will evaluate the effect of food, and the effect of omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be assigned to one of two treatment groups. Volunteers in both groups will receive oral doses of danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Adult healthy volunteers, aged 18 to 45 years, inclusive
• Weight >/= 50.0 kg
• Body Mass Index (BMI) 18.0 to 32.0 kg/m2, inclusive

Exclusion Criteria

• Presence of any active or chronic disease
• Abnormal blood pressure
• Abnormal resting heart rate
• Abnormal ECG values
• History of any clinically significant cardiovascular or cerebrovascular disease
• Current smokers or subjects that have discontinued smoking < 6 months prior to first dose of study drug
• Positive for hepatitis B, hepatitis C or HIV
• Positive test for drugs of abuse or alcohol
• Positive result for H. pylori
• Regular use of antacids, H-2 blockers, proton pump inhibitors, or any investigational drug within 30 days of first dose of study medication
• History of clinically significant gastrointestinal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	omeprazole	-
1	danoprevir	-
2	ranitidine	-
2	danoprevir	-
1	ritonavir	-
2	ritonavir	-

Primary Outcome Measures

Name	Time	Method
Effect of ranitidine on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir	1 day
Effect of omeprazole on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir	1 day
Food effect on area under the plasma concentration time curve of danoprevir when co-administered with ritonavir	1 day

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	Approximately 6 weeks