Skip to main content
OpenTrials
Completed

NCT Number: NCT01392755

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Danoprevir

Drug

oral doses of danoprevir

Omeprazole

Drug

oral doses of omeprazole

Ranitidine

Drug

oral dose of ranitidine

Ritonavir

Drug

oral doses of ritonavir

Primary outcomes

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

    Time frame: 1 day

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

    Time frame: 1 day

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

    Time frame: 1 day

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: Approximately 6 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 12, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.