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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392755
• Other study ID #: NP25291
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2011
• Last updated: November 1, 2016
• Start date: July 2011
• Est. completion date: September 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• danoprevir
oral doses of danoprevir
• omeprazole
oral doses of omeprazole
• ranitidine
oral dose of ranitidine
• ritonavir
oral doses of ritonavir

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of omeprazole on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir		1 day	No
Primary	Effect of ranitidine on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir		1 day	No
Primary	Food effect on area under the plasma concentration time curve of danoprevir when co-administered with ritonavir		1 day	No
Secondary	Safety: Incidence of adverse events		Approximately 6 weeks	No