A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer
Intervention: danoprevir (Drug); omeprazole (Drug); ranitidine (Drug); ritonavir (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
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.
Clinical Details
Official title: A Study to Evaluate the Effects of Two Different Meal Types, Omeprazole and Ranitidine on Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Effect of omeprazole on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavirEffect of ranitidine on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir Food effect on area under the plasma concentration time curve of danoprevir when co-administered with ritonavir
Secondary outcome: Safety: Incidence of adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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
Locations and Contacts
Lenexa, Kansas 66219, United States
Additional Information
Starting date: July 2011
Last updated: August 17, 2015
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