Huntington DiseasePhase 1NCT00788047
A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan
A Phase 1 study testing Dextromethorphan and Dimebon + Dextromethorphan in people with Huntington Disease and Alzheimer Disease, run by Pfizer at 1 site in United States.
Trial summary
This drug-drug interaction study is being conducted to evaluate the potential effect of Dimebon on the pharmacokinetics on dextromethorphan, a probe substrate of the cytochrome P450 2D6 (CYP2D6) enzyme, after multiple dose administration to healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease, Alzheimer Disease
- What is being tested?
- Dextromethorphan and Dimebon + Dextromethorphan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jan 2009
- 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
- Healthy adult subjects.
- Extensive or ultra-rapid metabolizers of CYP2D6 substrates, predicted by genotype.
Who cannot join
- Existence of significant medical conditions that would impact study results or pose unacceptable risks to study subjects.
- Pregnant or nursing females or females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon [PF-01913539] On The Single-Dose Pharmacokinetics Of The CYP2D6 Substrate Dextromethorphan In Healthy Subjects
This drug-drug interaction study is being conducted to evaluate the potential effect of Dimebon on the pharmacokinetics on dextromethorphan, a probe substrate of the cytochrome P450 2D6 (CYP2D6) enzyme, after multiple dose administration to healthy adult subjects.
- Conditions
- Huntington Disease, Alzheimer Disease
- Being tested
- Dextromethorphan, Dimebon + Dextromethorphan
- Medical subject headings
- Huntington Disease, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextromethorphanDrug
Dextromethorphan HCl 30 syrup single dose
Dimebon + DextromethorphanDrug
Dimebon 20 mg tablets given three times daily for 14 days plus Dextromethorphan HCl 30 syrup single dose administered on Day 12
| Study group | Role | What they receive |
|---|---|---|
| Regimen A (Reference) | Other | Not described Receives: Drug: Dextromethorphan |
| Regimen B (Test) | Experimental | Not described Receives: Drug: Dimebon + Dextromethorphan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone
Measured: Day 12
Secondary outcomes (2)
Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms)
Measured: Day 15
Dextrorphan (the metabolite of dextromethorphan) exposure
Measured: Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788047
- Sponsor's protocol ID
- B1451022
- Status last verified
- Mar 2009
- First submitted
- 7 Nov 2008
- Last updated
- 9 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon [PF-01913539] On The Single-Dose Pharmacokinetics Of The CYP2D6 Substrate Dextromethorphan In Healthy Subjects
- ClinicalTrials.gov ID
- NCT00788047
- Acronym / sponsor ID
- B1451022
- Conditions
- Huntington Disease, Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Study start
- Nov 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Nov 2008 (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 drug-drug interaction study is being conducted to evaluate the potential effect of Dimebon on the pharmacokinetics on dextromethorphan, a probe substrate of the cytochrome P450 2D6 (CYP2D6) enzyme, after multiple dose administration to healthy adult subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen A (Reference) | Other | Drug: Dextromethorphan |
| Regimen B (Test) | Experimental | Drug: Dimebon + Dextromethorphan |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult subjects.
- Extensive or ultra-rapid metabolizers of CYP2D6 substrates, predicted by genotype.
Key exclusion criteria (3 listed)
- Existence of significant medical conditions that would impact study results or pose unacceptable risks to study subjects.
- Pregnant or nursing females or females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days prior to the 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 |
|---|---|---|
| DextromethorphanDextromethorphan HCl 30 syrup single dose | Drug | Regimen A (Reference) |
| Dimebon + DextromethorphanDimebon 20 mg tablets given three times daily for 14 days plus Dextromethorphan HCl 30 syrup single dose administered on Day 12 | Drug | Regimen B (Test) |
Primary outcome
Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone
Time frame: Day 12
2 secondary outcomes
Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms)
Time frame: Day 15
Dextrorphan (the metabolite of dextromethorphan) exposure
Time frame: Day 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 9 Mar 2009.
- 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
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 Dextromethorphan and Dimebon + Dextromethorphan in people with Huntington Disease and Alzheimer Disease, run by Pfizer at 1 site 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 2 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 9 Mar 2009. 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 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?
Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone (time frame: Day 12). 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 9 Mar 2009.