Healthy VolunteerPhase 1NCT01389544
A Study on the Interaction Between Danoprevir/Ritonavir and Methadone
A Phase 1 study testing danoprevir, methadone and ritonavir in people with Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in United States.
Trial summary
This multicenter, open-label study will assess the effect of multiple doses of danoprevir/ritonavir on steady-state pharmacokinetics of methadone. Subjects on stable methadone maintenance therapy (20 - 120 mg daily as single oral morning dose) will receive danoprevir 100 mg orally twice daily and ritonavir 100 mg… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- danoprevir, methadone and ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Jul 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female adults, 18 - 65 years of age, inclusive
- Subjects must be on a stable methadone maintenance regimen (20 to 120 mg/day) for the treatment of opiate addiction for at least 30 days prior to screening and should be on a stable dose for at least 14 days prior to Day -1
- Body weight >/= 50 kg
- Body mass index (BMI) 18.0 - 32.0 kg/m2
- Females of childbearing potential and males with female partners of childbearing potential must agree to use 2 forms of non-hormonal contraception during the study and for 90 days after the last study drug administration
Who cannot join
- Pregnant or lactating women and male partners of women who are pregnant or lactating
- Symptoms of methadone withdrawal at screening, on Day -2 or Day -1
- Inadequate venous access
- History or evidence of any clinically significant disease or disorder, except for drug abuse or dependence
- Positive test for alcohol or drugs of abuse at screening and up to Day -2 (with the exception of methadone)
- History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol); alcohol consumption will be prohibited during study confinement and for at least 48 hours before screening, dosing and each scheduled visit
- Positive for hepatitis B, hepatitis C or HIV infection
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Anaheim, California, 92801
Study site
Overland Park, Kansas, 66211
About this study
Official title: Investigation of the Effect of Multiple Doses of Danoprevir/Ritonavir on Methadone in Subjects on Stable Methadone Maintenance Therapy (MMT)
This multicenter, open-label study will assess the effect of multiple doses of danoprevir/ritonavir on steady-state pharmacokinetics of methadone. Subjects on stable methadone maintenance therapy (20 - 120 mg daily as single oral morning dose) will receive danoprevir 100 mg orally twice daily and ritonavir 100 mg orally twice daily for 10 days.
- Conditions
- Healthy Volunteer
- Being tested
- danoprevir, methadone, ritonavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
danoprevirDrug
200 mg daily (100 mg q12h) orally, Days 1-10
methadoneDrug
stable maintenance therapy: 20-120 mg daily single oral morning dose
ritonavirDrug
200 mg daily (100 mg q12h) orally, Days 1-10
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: danoprevir; Drug: methadone; Drug: ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of danoprevir/ritonavir on steady state pharmacokinetics (area under the concentration - time curve (AUC)) of methadone
Measured: 10 days
Secondary outcomes (1)
Safety: Incidence of adverse events
Measured: approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2011
- Study completionJul 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT01389544
- Sponsor's protocol ID
- NP25644
- Status last verified
- Nov 2016
- First submitted
- 6 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
- Investigation of the Effect of Multiple Doses of Danoprevir/Ritonavir on Methadone in Subjects on Stable Methadone Maintenance Therapy (MMT)
- ClinicalTrials.gov ID
- NCT01389544
- Acronym / sponsor ID
- NP25644
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 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 multicenter, open-label study will assess the effect of multiple doses of danoprevir/ritonavir on steady-state pharmacokinetics of methadone. Subjects on stable methadone maintenance therapy (20 - 120 mg daily as single oral morning dose) will receive danoprevir 100 mg orally twice daily and ritonavir 100 mg orally twice daily for 10 days.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: danoprevir, Drug: methadone, Drug: ritonavir |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female adults, 18 - 65 years of age, inclusive
- Subjects must be on a stable methadone maintenance regimen (20 to 120 mg/day) for the treatment of opiate addiction for at least 30 days prior to screening and should be on a stable dose for at least 14 days prior to Day -1
- Body weight >/= 50 kg
- Body mass index (BMI) 18.0 - 32.0 kg/m2
- Females of childbearing potential and males with female partners of childbearing potential must agree to use 2 forms of non-hormonal contraception during the study and for 90 days after the last study drug administration
Key exclusion criteria (7 listed)
- Pregnant or lactating women and male partners of women who are pregnant or lactating
- Symptoms of methadone withdrawal at screening, on Day -2 or Day -1
- Inadequate venous access
- History or evidence of any clinically significant disease or disorder, except for drug abuse or dependence
- Positive test for alcohol or drugs of abuse at screening and up to Day -2 (with the exception of methadone)
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 |
|---|---|---|
| danoprevir200 mg daily (100 mg q12h) orally, Days 1-10 | Drug | Single Arm |
| methadonestable maintenance therapy: 20-120 mg daily single oral morning dose | Drug | Single Arm |
| ritonavir200 mg daily (100 mg q12h) orally, Days 1-10 | Drug | Single Arm |
Primary outcome
Effect of danoprevir/ritonavir on steady state pharmacokinetics (area under the concentration - time curve (AUC)) of methadone
Time frame: 10 days
1 secondary outcome
Safety: Incidence of adverse events
Time frame: approximately 4 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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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
2 sites 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, methadone and ritonavir in people with Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in United States.
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 5 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 2 sites in United States. 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?
Effect of danoprevir/ritonavir on steady state pharmacokinetics (area under the concentration - time curve (AUC)) of methadone (time frame: 10 days). 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.