Healthy VolunteerPhase 1NCT01483729
A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers
A Phase 1 study testing danoprevir and ritonavir in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in New Zealand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- danoprevir and ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNew Zealand
- Study dates
- Dec 2011to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Volunteer
- Being tested
- danoprevir, ritonavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
danoprevirDrug
Phase 3 Tablet Formulation 1, single oral dose
danoprevirDrug
Phase 3 Tablet Formulation 2, single oral dose
danoprevirDrug
Reference Phase 2 Tablet Formulation, single oral dose
ritonavirDrug
Test Formulation 1, single oral dose
ritonavirDrug
Test Formulation 2, single oral dose
ritonavirDrug
Reference Formulation, single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Part 1 A | Active comparator | Not described Receives: Drug: danoprevir; Drug: ritonavir |
| Part 1 B | Experimental | Not described Receives: Drug: danoprevir; Drug: ritonavir |
| Part 1 C | Experimental | Not described Receives: Drug: danoprevir; Drug: ritonavir |
| Part 2 D | Active comparator | Not described Receives: Drug: danoprevir; Drug: ritonavir |
| Part 2 E | Experimental | Not described Receives: Drug: danoprevir; Drug: ritonavir |
| Part 2 F | Experimental | Not described Receives: Drug: danoprevir; Drug: ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Danoprevir bioavailabilty (Tablet Formulation 1) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC)
Measured: 24 hours
Part 1: Danoprevir bioavailability (Tablet Formulation 2) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC)
Measured: 24 hours
Part 2: Ritonavir bioavailability (Test Formulation 1) in combination with danoprevir (refernce formulation): Area under the concentration-time curve (AUC)
Measured: 24 hours
Part 2: Ritonavir bioavailability (Test Formulation 2) in combination with danoprevir (reference formulation): Area under the concentration-time curve (AUC)
Measured: 24 hours
Secondary outcomes (1)
Safety: Incidence of adverse events
Measured: approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483729
- Sponsor's protocol ID
- NP27945
- Other IDs
- RPU425UD-114254
- Status last verified
- Nov 2016
- First submitted
- 30 Nov 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01483729
- Acronym / sponsor ID
- NP27945
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 A | Active comparator | Drug: danoprevir, Drug: ritonavir |
| Part 1 B | Experimental | Drug: danoprevir, Drug: ritonavir |
| Part 1 C | Experimental | Drug: danoprevir, Drug: ritonavir |
| Part 2 D | Active comparator | Drug: danoprevir, Drug: ritonavir |
| Part 2 E | Experimental | Drug: danoprevir, Drug: ritonavir |
| Part 2 F | Experimental | Drug: danoprevir, Drug: ritonavir |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| danoprevirPhase 3 Tablet Formulation 1, single oral dose | Drug | Part 1 B |
| danoprevirPhase 3 Tablet Formulation 2, single oral dose | Drug | Part 1 C |
| danoprevirReference Phase 2 Tablet Formulation, single oral dose | Drug | Part 1 A, Part 2 D, Part 2 E, Part 2 F |
| ritonavirTest Formulation 1, single oral dose | Drug | Part 2 E |
| ritonavirTest Formulation 2, single oral dose | Drug | Part 2 F |
| ritonavirReference Formulation, single oral dose | Drug | Part 1 A, Part 1 B, Part 1 C, Part 2 D |
Primary outcome
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
1 secondary outcome
Safety: Incidence of adverse events
Time frame: approximately 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing danoprevir and ritonavir in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Danoprevir bioavailabilty (Tablet Formulation 1) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC) (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.