Healthy VolunteerPhase 1NCT01398293
A Study of Danoprevir in Combination With Low-Dose Ritonavir in Healthy Subjects
A Phase 1 study testing danoprevir, moxifloxacin and ritonavir in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in France.
Trial summary
This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- danoprevir, moxifloxacin and ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to Nov 2011
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult healthy volunteers, 18 - 60 years of age
- Female subjects must be surgically sterile or post-menopausal
- Male subjects and their partners of child-bearing potential must use to methods of contraception for the duration of the study and for three months after the last drug administration
- Agree to abstain from strenuous exercise for three days before dosing and throughout the study (including washout period and follow-up visit)
Who cannot join
- History or evidence of any clinically significant disease or disorder
- Pregnant or lactating women
- Male partners of women who are lactating or trying to become pregnant
- Current smokers or subjects who have discontinued smoking less than six months prior to first dosing
- Positive alcohol breath test; suspicion of regular consumption of drugs of abuse
- Positive for hepatitis B, hepatitis C or HIV infection
- Participation in an investigational drug, biologic, or device study within three months before first study drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Single-dose, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Four-way Crossover Study to Investigate the Effect of Danoprevir With Low Dose Ritonavir (DNV/r) on the QT/QTc Interval in Healthy Subjects
This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.
- Conditions
- Healthy Volunteer
- Being tested
- danoprevir, danoprevir placebo, moxifloxacin, moxifloxacin placebo, ritonavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
danoprevirDrug
100 mg single dose orally
danoprevirDrug
400 mg single dose orally
danoprevir placeboDrug
single oral dose
moxifloxacinDrug
400 mg single dose orally
moxifloxacin placeboDrug
single oral dose
ritonavirDrug
100 mg single dose orally
ritonavir placeboDrug
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: danoprevir; Drug: moxifloxacin placebo; Drug: ritonavir |
| B | Experimental | Not described Receives: Drug: danoprevir; Drug: moxifloxacin placebo; Drug: ritonavir |
| C | Active comparator | Not described Receives: Drug: danoprevir placebo; Drug: moxifloxacin; Drug: ritonavir placebo |
| D | Placebo comparator | Not described Receives: Drug: danoprevir placebo; Drug: moxifloxacin placebo; Drug: ritonavir placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose
Measured: approximately 9 weeks
Secondary outcomes (4)
Pharmacokinetics: Plasma concentrations
Measured: approximately 9 weeks
Safety: Incidence of adverse events
Measured: approximately 9 weeks
Cardiac response: Electrocardiogram (ECG)
Measured: approximately 9 weeks
Correlation between pharmacokinetics (plasma concentrations) and QT/QTc interval changes
Measured: approximately 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2011
- Study completionNov 2011
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 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
- NCT01398293
- Sponsor's protocol ID
- NP25298
- Other IDs
- 2011-001413-13
- Status last verified
- Nov 2016
- First submitted
- 19 Jul 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 Single-center, Single-dose, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Four-way Crossover Study to Investigate the Effect of Danoprevir With Low Dose Ritonavir (DNV/r) on the QT/QTc Interval in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01398293
- Acronym / sponsor ID
- NP25298
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Jul 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, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: danoprevir, Drug: moxifloxacin placebo, Drug: ritonavir |
| B | Experimental | Drug: danoprevir, Drug: moxifloxacin placebo, Drug: ritonavir |
| C | Active comparator | Drug: danoprevir placebo, Drug: moxifloxacin, Drug: ritonavir placebo |
| D | Placebo comparator | Drug: danoprevir placebo, Drug: moxifloxacin placebo, Drug: ritonavir placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult healthy volunteers, 18 - 60 years of age
- Female subjects must be surgically sterile or post-menopausal
- Male subjects and their partners of child-bearing potential must use to methods of contraception for the duration of the study and for three months after the last drug administration
- Agree to abstain from strenuous exercise for three days before dosing and throughout the study (including washout period and follow-up visit)
Key exclusion criteria (7 listed)
- History or evidence of any clinically significant disease or disorder
- Pregnant or lactating women
- Male partners of women who are lactating or trying to become pregnant
- Current smokers or subjects who have discontinued smoking less than six months prior to first dosing
- Positive alcohol breath test; suspicion of regular consumption of drugs of abuse
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 |
|---|---|---|
| danoprevir100 mg single dose orally | Drug | A |
| danoprevir400 mg single dose orally | Drug | B |
| danoprevir placebosingle oral dose | Drug | C, D |
| moxifloxacin400 mg single dose orally | Drug | C |
| moxifloxacin placebosingle oral dose | Drug | A, B, D |
| ritonavir100 mg single dose orally | Drug | A, B |
| ritonavir placebosingle oral dose | Drug | C, D |
Primary outcome
Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose
Time frame: approximately 9 weeks
4 secondary outcomes
Pharmacokinetics: Plasma concentrations
Time frame: approximately 9 weeks
Safety: Incidence of adverse events
Time frame: approximately 9 weeks
Cardiac response: Electrocardiogram (ECG)
Time frame: approximately 9 weeks
Correlation between pharmacokinetics (plasma concentrations) and QT/QTc interval changes
Time frame: approximately 9 weeks
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, moxifloxacin and ritonavir in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in France.
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 4 inclusion and 7 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 France. 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. Some participants in this study may receive a placebo. 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?
Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose (time frame: approximately 9 weeks). 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.