Christchurch, 8011, New Zealand
NCT Number: NCT01592318
A Study of The Relative Bioavailability of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets in Healthy Volunteers
This randomized, open-label, crossover study will evaluate the relative bioavailability of ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an FDC of danoprevir and ritonavir or danoprevir and ritonavir as separate tablets. In a crossover design, subjects will participate in 3 study periods with at least a 7-day washout between periods. In Part 2, single dose administration of film-coated FDCs will be compared to reference tablets.
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Notify MeKey information
Conditions
Age range
18 year–55 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
- Male and female volunteers, 18 to 55 years of age
- Body weight >/= 50.0 kg
- Body mass index (BMI) 18.0 - 32.0 kg/m2
- Healthy non-smoking subjects. Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- 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, 1 of which must be a barrier method, 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
- Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections
- Positive result 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
- Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication
- Use of hormonal contraceptives (e.g. birth control pills, patches, injectable, implantable devices) within 30 days before the first dose of study medication
- Use of an investigational drug or device within 30 days of the first dose of study medication (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
- History of drug-related allergic reactions or hepatotoxicity
- History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average
Treatment and study plan
Danoprevir
DrugFixed dose combination tablet with ritonavir, single oral dose
Ritonavir
DrugFixed dose combination tablet with danoprevir, single oral dose
Primary outcomes
-
Relative bioavailability of danoprevir: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 24 hours post-dose Days 1, 8 and 15
-
Pharmacokinetics of ritonavir: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 24 hours post-dose Days 1, 8 and 15
Secondary outcomes
-
Safety: Incidence of adverse events
Time frame: approximately 2 months
Sponsors and collaborators
Lead sponsor
Hoffmann-La Roche
Industry
Registry information
Official study title
An Up to Two-Part Relative Bioavailability Study of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets as Compared to the Reference Phase 2 Ad Hoc Combination Tablets in Healthy Adult Volunteers
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- May 7, 2012
- 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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