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

A Study to Evaluate the Effects of Two Different Meal Types, Omeprazole and Ranitidine on Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01392755

Enrollment

Registered

2011-07-12

Start date

2011-07-31

Completion date

2011-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief 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.

Interventions

DRUGdanoprevir

oral doses of danoprevir

DRUGomeprazole

oral doses of omeprazole

DRUGranitidine

oral dose of ranitidine

DRUGritonavir

oral doses of ritonavir

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Effect of omeprazole on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir	1 day
Effect of ranitidine on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir	1 day
Food effect on area under the plasma concentration time curve of danoprevir when co-administered with ritonavir	1 day

Secondary

Measure	Time frame
Safety: Incidence of adverse events	Approximately 6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026