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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 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 ritonavir

Effect 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

Page last updated: August 23, 2015

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