Chronic Hepatitis CPhase 1NCT01210404
Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance
A Phase 1 study testing filibuvir in people with Chronic Hepatitis C, run by Pfizer at 2 sites in United States.
Trial summary
Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C infection. Given the likelihood of co administration of filibuvir and methadone, this study will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- filibuvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, without evidence of infection with HIV,HBV or HCV, who are on chronic methadone maintenance for at least three months and at a stable dose for at least 1 week prior to study start.
Who cannot join
- Evidence of chronic diseases including HIV, HBV or HCV.
- Evidence of acute or chronic liver disease.
- Treatment with prescription or nonprescription drugs other than methadone within 7 days.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Overland Park, Kansas, 66212
About this study
Official title: Open Label Single Sequence Study To Estimate The Effect Of Filibuvir (PF-00868554) On S-And R-Methadone In Subjects Receiving Chronic Methadone Treatment And To Evaluate The Pharmacokinetics Of Filibuvir
Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C infection. Given the likelihood of co administration of filibuvir and methadone, this study will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.
- Conditions
- Chronic Hepatitis C
- Being tested
- filibuvir
- Keywords
- Drug interaction with methadone.
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filibuvirDrug
Filibuvir, 600mg bid administered along with methadone on days 2-11
| Study group | Role | What they receive |
|---|---|---|
| 1.0 | Experimental | Not described Receives: Drug: filibuvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methadone plasma pharmacokinetic parameters, AUC24, Cmax
Measured: day 1
Methadone plasma pharmacokinetic parameters, AUC24, Cmax
Measured: day 11
Secondary outcomes (6)
Methadone plasma pharmacokinetic parameters Tmax and C24h
Measured: day 1
Methadone plasma pharmacokinetic parameters Tmax and C24h
Measured: day 11
Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.
Measured: day 2
Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.
Measured: day 11
Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments.
Measured: days 0-12
Symptoms of methadone withdrawal as assessed by short Opiate Withdrawal Scale, Desires for Drug questionnaire and pupillary diameter measurement .
Measured: days 0-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210404
- Sponsor's protocol ID
- A8121023
- Status last verified
- Jun 2011
- First submitted
- 27 Sep 2010
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Single Sequence Study To Estimate The Effect Of Filibuvir (PF-00868554) On S-And R-Methadone In Subjects Receiving Chronic Methadone Treatment And To Evaluate The Pharmacokinetics Of Filibuvir
- ClinicalTrials.gov ID
- NCT01210404
- Acronym / sponsor ID
- A8121023
- Conditions
- Chronic Hepatitis C
- Keywords
- Drug interaction with methadone.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Sep 2010 (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.
Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C infection. Given the likelihood of co administration of filibuvir and methadone, this study will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1.0 | Experimental | Drug: filibuvir |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males or females, without evidence of infection with HIV,HBV or HCV, who are on chronic methadone maintenance for at least three months and at a stable dose for at least 1 week prior to study start.
Key exclusion criteria (3 listed)
- Evidence of chronic diseases including HIV, HBV or HCV.
- Evidence of acute or chronic liver disease.
- Treatment with prescription or nonprescription drugs other than methadone within 7 days.
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 |
|---|---|---|
| filibuvirFilibuvir, 600mg bid administered along with methadone on days 2-11 | Drug | 1.0 |
Primary outcome
Methadone plasma pharmacokinetic parameters, AUC24, Cmax
Time frame: day 1
Methadone plasma pharmacokinetic parameters, AUC24, Cmax
Time frame: day 11
6 secondary outcomes
Methadone plasma pharmacokinetic parameters Tmax and C24h
Time frame: day 1
Methadone plasma pharmacokinetic parameters Tmax and C24h
Time frame: day 11
Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.
Time frame: day 2
Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.
Time frame: day 11
Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments.
Time frame: days 0-12
Symptoms of methadone withdrawal as assessed by short Opiate Withdrawal Scale, Desires for Drug questionnaire and pupillary diameter measurement .
Time frame: days 0-12
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 7 Jun 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 filibuvir in people with Chronic Hepatitis C, run by Pfizer 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 1 inclusion and 3 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 7 Jun 2011. 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?
Methadone plasma pharmacokinetic parameters, AUC24, Cmax (time frame: day 1). 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 7 Jun 2011.