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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Lactams; Omeprazole; Ranitidine; Ranitidine bismuth citrate; Ritonavir

Criteria

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