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

NCT01392755 | Completed Phase 1

• 1 other identifier: NP25291
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Safety: Incidence of adverse events

  Approximately 6 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: danoprevir; Drug: ritonavir

2

EXPERIMENTAL

Drug: danoprevir; Drug: omeprazole; Drug: ranitidine; Drug: ritonavir

Interventions

danoprevir DRUG

oral doses of danoprevir

1; 2

omeprazole DRUG

oral doses of omeprazole

2

ranitidine DRUG

oral dose of ranitidine

2

ritonavir DRUG

oral doses of ritonavir

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

danoprevir; Omeprazole; Ranitidine; Ritonavir

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Furans; Thiazoles; Azoles

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 12, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)