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

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Evaluate the Effects of Two Different Meal Types, Omeprazole and Ranitidine on Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Subjects

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: danoprevir
* Drug: omeprazole
* Drug: ranitidine
* Drug: ritonavir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: danoprevir<br>* oral doses of danoprevir<br>Drug: ritonavir<br>* oral doses of ritonavir<br>|
| Experimental: 2<br> | Drug: danoprevir<br>* oral doses of danoprevir<br>Drug: omeprazole<br>* oral doses of omeprazole<br>Drug: ranitidine<br>* oral dose of ranitidine<br>Drug: ritonavir<br>* oral doses of ritonavir<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of omeprazole on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir |  | 1 day | 
| Effect of ranitidine 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | Approximately 6 weeks |