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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01392755
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 15.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: danoprevir; Drug: omeprazole; Drug: ranitidine; Drug: ritonavir	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jul 1, 2011
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

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: omeprazole; oral doses of omeprazole; Drug: ranitidine; oral dose of ranitidine; Drug: ritonavir; oral doses of ritonavir

Outcome Measures

Primary Outcome Measures

1. Effect of omeprazole on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir [1 day]

2. Effect of ranitidine on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir [1 day]

3. Food effect on area under the plasma concentration time curve of danoprevir when co-administered with ritonavir [1 day]

Secondary Outcome Measures

1. Safety: Incidence of adverse events [Approximately 6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Lenexa	Kansas	United States	66219

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01392755
• Other Study ID Numbers: NP25291
• First Posted: Jul 12, 2011
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Ritonavir; Omeprazole; Ranitidine; Ranitidine bismuth citrate

Study Results

No Results Posted as of Nov 2, 2016