Christchurch, 8011, New Zealand
NCT Number: NCT01483729
A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers
This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will evaluate the relative bioavailability of danoprevir and ritonavir in healthy volunteers. In Part 1, subjects will be randomized to receive single oral doses of one of three tablet formulations of danoprevir plus the reference ritonavir formulation, with an at least 7-day washout between periods. In Part 2, subjects will be randomized to receive single oral doses of one of three tablet formulations of ritonavir plus the reference formulation of danoprevir, with at least a 7-day washout betwen periods. The anticipated time on study is up to 30 days.
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy volunteers, 18 to 45 years of age inclusive
- Body mass index 18.0 - 32.0 kg/m2, weight >/= 50 kg
- Healthy status will be defined as absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- Non-smoker
- Medical history without major, recent or ongoing pathology
- Females of childbearing potential and males and their female partners of childbearing potential must agree to use 2 forms of contraception (barrier form plus intrauterine device and spemicide) during the study and for 90 days after the last drug administration
Exclusion criteria
- Pregnant or lactating women or males with female partners who are pregnant or lactating
- Positive results for drugs of abuse at screening or prior to admission to the clinical site during any study period
- Positive for hepatitis B, hepatitis C or HIV infection
- Use of hormonal contraceptives (birth control pills, injectable, implantable devices) within 30 days before the first dose of study medication
- Routine use of more than 2 g of acetaminophen daily
- History of clinically significant drug allergy (such as anaphylaxis) or hepatotoxicity
- History of hypersensitivity to danoptevir, ritonavir, or other protease inhibitors
- History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average
- Current enrollment or participation in a clinical trial of an experimental medication or medical device within 3 months of screening unless agreed upon by the Sponsor
Treatment and study plan
Danoprevir
DrugPhase 3 Tablet Formulation 1, single oral dose
Ritonavir
DrugTest Formulation 1, single oral dose
Primary outcomes
-
Part 1: Danoprevir bioavailabilty (Tablet Formulation 1) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC)
Time frame: 24 hours
-
Part 1: Danoprevir bioavailability (Tablet Formulation 2) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC)
Time frame: 24 hours
-
Part 2: Ritonavir bioavailability (Test Formulation 1) in combination with danoprevir (refernce formulation): Area under the concentration-time curve (AUC)
Time frame: 24 hours
-
Part 2: Ritonavir bioavailability (Test Formulation 2) in combination with danoprevir (reference formulation): Area under the concentration-time curve (AUC)
Time frame: 24 hours
Secondary outcomes
-
Safety: Incidence of adverse events
Time frame: approximately 4 months
Sponsors and collaborators
Lead sponsor
Hoffmann-La Roche
Industry
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Dec 1, 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.
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