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

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: danoprevir

Drug: ranitidine

Drug: omeprazole

Drug: ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01392755

NP25291

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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