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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01392755
First received: July 11, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This randomized, open-label study will evaluate the effect of food, and the effe ct of omeprazole and ranitidine on danoprevir co-administered with ritonavir. Vo lunteers will be assigned to one of two treatment groups. Volunteers in both gro ups will receive oral doses of danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of omeprazole and ranitidine. The anticipate d time of the study is approximately 6 weeks.


Condition Intervention Phase
Healthy Volunteer
Drug: danoprevir
Drug: ritonavir
Drug: omeprazole
Drug: ranitidine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effect of omeprazole on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Effect of ranitidine on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Food effect on area under the plasma concentration time curve of danoprevir when co-administered with ritonavir [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: Approximately 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392755

Locations
United States, Kansas
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01392755     History of Changes
Other Study ID Numbers: NP25291
Study First Received: July 11, 2011
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Omeprazole
Ranitidine
Ranitidine bismuth citrate
Ritonavir
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 20, 2014