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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01592318




Registration number
NCT01592318
Ethics application status
Date submitted
24/04/2012
Date registered
3/05/2012
Date last updated
1/11/2016

Titles & IDs
Public title
A Study of The Relative Bioavailability of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
NP28136
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - danoprevir
Treatment: Drugs - danoprevir
Treatment: Drugs - ritonavir
Treatment: Drugs - ritonavir

Active Comparator: DNV + r reference -

Experimental: DNV/r fixed dose combination -


Treatment: Drugs: danoprevir
Fixed dose combination tablet with ritonavir, single oral dose

Treatment: Drugs: danoprevir
Reference tablet, single oral dose

Treatment: Drugs: ritonavir
Fixed dose combination tablet with danoprevir, single oral dose

Treatment: Drugs: ritonavir
Reference tablet, single oral dose

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relative bioavailability of danoprevir: Area under the concentration-time curve (AUC)
Timepoint [1] 0 0
Pre-dose and up to 24 hours post-dose Days 1, 8 and 15
Primary outcome [2] 0 0
Pharmacokinetics of ritonavir: Area under the concentration-time curve (AUC)
Timepoint [2] 0 0
Pre-dose and up to 24 hours post-dose Days 1, 8 and 15
Secondary outcome [1] 0 0
Safety: Incidence of adverse events
Timepoint [1] 0 0
approximately 2 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01592318
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications