Healthy VolunteersPhase 1NCT00999817
A Pharmacokinetic (PK) Study Of PF-00299804 And Dextromethorphan In Healthy Volunteers
A Phase 1 study testing reference [dextromethorphan] and test [PF-00299804 + dextromethorphan] in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.
Trial summary
A study to study the potential effect of PF-00299804 inhibition of CYP2D6 on dextromethorphan. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- reference [dextromethorphan] and test [PF-00299804 + 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 siteBelgium
- Study dates
- Nov 2009to Dec 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 male and/or female of non childbearing potential subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Subjects must be CYP2D6 extensive metabolizers, ultrarapid metabolizers or intermediate metabolizers, as predicted by CYP2D6 genotyping.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink =5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives preceding the first dose of study medication.
- 12 lead ECG demonstrating QTc >450 msec at Screening. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
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- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. Depo Provera® must be discontinued at least 6 months prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of <1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results the study may be permitted on a case by case basis.
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
- History of sensitivity to heparin or heparin induced thrombocytopenia.
- Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Phase 1, Randomized Cross Over Trial To Estimate The Effect Of PF- 00299804 On The Pharmacokinetics Of Dextromethorphan In Healthy Volunteers
A study to study the potential effect of PF-00299804 inhibition of CYP2D6 on dextromethorphan.
- Conditions
- Healthy Volunteers
- Being tested
- reference [dextromethorphan], test [PF-00299804 + dextromethorphan]
- Keywords
- Drug-Drug interaction Study CYP2D6 inhibition Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reference [dextromethorphan]Drug
single 30 mg oral dose
test [PF-00299804 + dextromethorphan]Drug
single 45 mg oral dose of PF-00299804 and a single 30 mg oral dose of dextromethorphan
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Single 30 mg dose of dextromethorphan Receives: Drug: reference [dextromethorphan] |
| B | Experimental | Single 45 mg dose of PF-00299804 plus a single 30 mg oral dose of dextromethorphan Receives: Drug: test [PF-00299804 + dextromethorphan] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma AUCinf, AUClast and Cmax of dextromethorphan and dextrorphan when given alone and when given in combination with PF- 00299804.
Measured: 7 weeks
Secondary outcomes (3)
Plasma Tmax, t1/2, for dextromethorphan and dextrorphan and CL/F, and V/F for dextromethorphan (as data permit).
Measured: 7 weeks
Plasma AUCinf, AUClast, Cmax, Tmax, t1/2, CL/F, and V/F (as data permit) of PF 00299804 when given alone.
Measured: 7 weeks
Safety laboratory tests, physical examination, concomitant medication and adverse event monitoring.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999817
- Sponsor's protocol ID
- A7471039
- Status last verified
- Jan 2010
- First submitted
- 8 Oct 2009
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 1, Randomized Cross Over Trial To Estimate The Effect Of PF- 00299804 On The Pharmacokinetics Of Dextromethorphan In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00999817
- Acronym / sponsor ID
- A7471039
- Conditions
- Healthy Volunteers
- Keywords
- Drug-Drug interaction Study CYP2D6 inhibition Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Oct 2009 (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.
A study to study the potential effect of PF-00299804 inhibition of CYP2D6 on dextromethorphan.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: reference [dextromethorphan]Single 30 mg dose of dextromethorphan |
| B | Experimental | Drug: test [PF-00299804 + dextromethorphan]Single 45 mg dose of PF-00299804 plus a single 30 mg oral dose of dextromethorphan |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Subjects must be CYP2D6 extensive metabolizers, ultrarapid metabolizers or intermediate metabolizers, as predicted by CYP2D6 genotyping.
Key exclusion criteria (10 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink =5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives preceding 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 |
|---|---|---|
| reference [dextromethorphan]single 30 mg oral dose | Drug | A |
| test [PF-00299804 + dextromethorphan]single 45 mg oral dose of PF-00299804 and a single 30 mg oral dose of dextromethorphan | Drug | B |
Primary outcome
Plasma AUCinf, AUClast and Cmax of dextromethorphan and dextrorphan when given alone and when given in combination with PF- 00299804.
Time frame: 7 weeks
3 secondary outcomes
Plasma Tmax, t1/2, for dextromethorphan and dextrorphan and CL/F, and V/F for dextromethorphan (as data permit).
Time frame: 7 weeks
Plasma AUCinf, AUClast, Cmax, Tmax, t1/2, CL/F, and V/F (as data permit) of PF 00299804 when given alone.
Time frame: 7 weeks
Safety laboratory tests, physical examination, concomitant medication and adverse event monitoring.
Time frame: 7 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 7 Jan 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
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 reference [dextromethorphan] and test [PF-00299804 + dextromethorphan] in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.
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 3 inclusion and 10 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 Jan 2010. 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 Belgium. 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?
Plasma AUCinf, AUClast and Cmax of dextromethorphan and dextrorphan when given alone and when given in combination with PF- 00299804. (time frame: 7 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 7 Jan 2010.