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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: danoprevir; Drug: ritonavir; Drug: omeprazole; Drug: ranitidine

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: danoprevir; oral doses of danoprevir; Drug: ritonavir; oral doses of ritonavir
Experimental: 2	Drug: danoprevir; oral doses of danoprevir; Drug: ritonavir; oral doses of ritonavir; Drug: omeprazole; oral doses of omeprazole; Drug: ranitidine; oral dose of ranitidine

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events	Approximately 6 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: July 11, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Gastrointestinal Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists; Ritonavir; Omeprazole; Ranitidine; Ranitidine bismuth citrate
• Other Study ID Numbers: NP25291