Healthy VolunteerPhase 1NCT01592318
A Study of The Relative Bioavailability of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets 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 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. Read more about this study
- Who is it for?
- Ages 18 to 55 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
- 42 participants
- Where
- 1 siteNew Zealand
- Study dates
- May 2012to Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- 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
Fixed dose combination tablet with ritonavir, single oral dose
danoprevirDrug
Reference tablet, single oral dose
ritonavirDrug
Fixed dose combination tablet with danoprevir, single oral dose
ritonavirDrug
Reference tablet, single oral dose
| Study group | Role | What they receive |
|---|---|---|
| DNV + r reference | Active comparator | Not described Receives: Drug: danoprevir; Drug: ritonavir |
| DNV/r fixed dose combination | 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.
Relative bioavailability of danoprevir: Area under the concentration-time curve (AUC)
Measured: Pre-dose and up to 24 hours post-dose Days 1, 8 and 15
Pharmacokinetics of ritonavir: Area under the concentration-time curve (AUC)
Measured: Pre-dose and up to 24 hours post-dose Days 1, 8 and 15
Secondary outcomes (1)
Safety: Incidence of adverse events
Measured: approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionJun 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT01592318
- Sponsor's protocol ID
- NP28136
- Status last verified
- Nov 2016
- First submitted
- 24 Apr 2012
- 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
- 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
- ClinicalTrials.gov ID
- NCT01592318
- Acronym / sponsor ID
- NP28136
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 May 2012 (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 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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DNV + r reference | Active comparator | Drug: danoprevir, Drug: ritonavir |
| DNV/r fixed dose combination | Experimental | Drug: danoprevir, Drug: ritonavir |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| danoprevirFixed dose combination tablet with ritonavir, single oral dose | Drug | DNV/r fixed dose combination |
| danoprevirReference tablet, single oral dose | Drug | DNV + r reference |
| ritonavirFixed dose combination tablet with danoprevir, single oral dose | Drug | DNV/r fixed dose combination |
| ritonavirReference tablet, single oral dose | Drug | DNV + r reference |
Primary outcome
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
1 secondary outcome
Safety: Incidence of adverse events
Time frame: approximately 2 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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Screening Protocol
Pain
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?
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). The study lists 2 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.