Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01483729




Registration number
NCT01483729
Ethics application status
Date submitted
30/11/2011
Date registered
1/12/2011
Date last updated
2/11/2016

Titles & IDs
Public title
A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers
Scientific title
Secondary ID [1] 0 0
RPU425UD-114254
Secondary ID [2] 0 0
NP27945
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 - danoprevir
Treatment: Drugs - ritonavir
Treatment: Drugs - ritonavir
Treatment: Drugs - ritonavir

Active comparator: Part 1 A -

Experimental: Part 1 B -

Experimental: Part 1 C -

Active comparator: Part 2 D -

Experimental: Part 2 E -

Experimental: Part 2 F -


Treatment: Drugs: danoprevir
Phase 3 Tablet Formulation 1, single oral dose

Treatment: Drugs: danoprevir
Phase 3 Tablet Formulation 2, single oral dose

Treatment: Drugs: danoprevir
Reference Phase 2 Tablet Formulation, single oral dose

Treatment: Drugs: ritonavir
Test Formulation 1, single oral dose

Treatment: Drugs: ritonavir
Test Formulation 2, single oral dose

Treatment: Drugs: ritonavir
Reference Formulation, single oral dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Danoprevir bioavailabilty (Tablet Formulation 1) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC)
Timepoint [1] 0 0
24 hours
Primary outcome [2] 0 0
Part 1: Danoprevir bioavailability (Tablet Formulation 2) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC)
Timepoint [2] 0 0
24 hours
Primary outcome [3] 0 0
Part 2: Ritonavir bioavailability (Test Formulation 1) in combination with danoprevir (refernce formulation): Area under the concentration-time curve (AUC)
Timepoint [3] 0 0
24 hours
Primary outcome [4] 0 0
Part 2: Ritonavir bioavailability (Test Formulation 2) in combination with danoprevir (reference formulation): Area under the concentration-time curve (AUC)
Timepoint [4] 0 0
24 hours
Secondary outcome [1] 0 0
Safety: Incidence of adverse events
Timepoint [1] 0 0
approximately 4 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
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
* 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

Study design
Purpose of the study
Treatment
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
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
36
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 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.
Trial website
https://clinicaltrials.gov/study/NCT01483729
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01483729