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

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT01392755

Run by

Hoffmann-La Roche

People needed

32

Starts

2011-07-01

Expected to finish

2011-09-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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