Healthy VolunteersPhase 1NCT01318031
Study To Investigate The Potential Drug Drug Interaction (DDI) Between PF-00299804 And Paroxetine In Healthy Subjects
A Phase 1 study testing Period 1 and Period 2 in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial summary
Study of a drug drug interaction between Paroxetine and PF-00299804. 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?
- Period 1 and Period 2
- 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
- Mar 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
- Healthy males or females of non-childbearing potential between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Subjects must be extensive CYP2D6 metabolizers as determined by genotyping.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, dermatologic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- History of depression or other potential for increased suicidality with paroxetine.
- Family or personal medical history of prolonged QTc, congenital deafness or sudden death, or 12-lead ECG with QTc>450 msec.
- A positive urine drug screen, use of tobacco or nicotine-containing products, or regular alcohol consumption exceeding 14 drinks/ week for females or 21 drinks/week for men within prior 6 months.
- Pregnant or nursing females and females of childbearing potential including those with tubal ligation. Women of 45 to 55 years of age who are postmenopausal must have confirmatory FSH test results at screening.
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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.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: Phase 1 Single Dose Open Label Study To Investigate The Potential DDI Between PF-00299804 And Paroxetine In Healthy Subjects
Study of a drug drug interaction between Paroxetine and PF-00299804.
- Conditions
- Healthy Volunteers
- Being tested
- Period 1, Period 2
- Keywords
- DDI, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Period 1Drug
Subjects will receive a single 45 mg dose of PF-00299804 on Day 1 of Period 1.
Period 2Drug
Subjects will receive a single 30 mg tablet of paroxetine once daily for 3 days (Days 1 to 3). Then, subjects will be co-administered a 45 mg single dose of PF-00299804 plus a single dose of 30 mg paroxetine on Day 4. Single 30 mg doses of paroxetine will be administered once daily for 6 days (Days 5-10).
| Study group | Role | What they receive |
|---|---|---|
| DDI | Experimental | Not described Receives: Drug: Period 1; Drug: Period 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma AUCinf of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
Measured: 8 weeks
Plasma AUCt of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
Measured: 8 weeks
Plasma Cmax of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
Measured: 8 weeks
Plasma AUCinf of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
Measured: 8 weeks
Plasma AUCt of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
Measured: 8 weeks
Plasma Cmax of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
Measured: 8 weeks
Secondary outcomes (14)
Plasma CL/F of PF-00299804 in EM without paroxetine.
Measured: 8 weeks
Plasma Tmax of PF-00299804 in EM without paroxetine.
Measured: 8 weeks
Plasma t1/2 of PF-00299804 in EM without paroxetine.
Measured: 8 weeks
Plasma MRT of PF-00299804 in EM without paroxetine.
Measured: 8 weeks
Plasma CL/F of PF-00299804 in EM with paroxetine.
Measured: 8 weeks
Plasma Tmax of PF-00299804 in EM with paroxetine.
Measured: 8 weeks
Plasma t1/2 of PF-00299804 in EM with paroxetine.
Measured: 8 weeks
Plasma MRT of PF-00299804 in EM with paroxetine.
Measured: 8 weeks
Plasma AUCinf of PF-05199265 in EMs when given alone (if levels permit).
Measured: 8 weeks
Plasma AUCt of PF-05199265 in EMs when given alone (if levels permit).
Measured: 8 weeks
Plasma Cmax of PF-05199265 in EMs when given alone (if levels permit).
Measured: 8 weeks
Plasma Tmax of PF-05199265 in EMs when given in combination with paroxetine (if levels permit).
Measured: 8 weeks
Plasma t1/2 of PF-05199265 in EMs when given in combination with paroxetine (if levels permit).
Measured: 8 weeks
Overall safety profile as characterized by laboratory abnormalities, observed physical examination, vital signs, ECGs, and adverse event monitoring.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318031
- Sponsor's protocol ID
- A7471021
- Status last verified
- Jun 2012
- First submitted
- 17 Feb 2011
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Single Dose Open Label Study To Investigate The Potential DDI Between PF-00299804 And Paroxetine In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01318031
- Acronym / sponsor ID
- A7471021
- Conditions
- Healthy Volunteers
- Keywords
- DDI, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Mar 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.
Study of a drug drug interaction between Paroxetine and PF-00299804.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DDI | Experimental | Drug: Period 1, Drug: Period 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males or females of non-childbearing potential between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Subjects must be extensive CYP2D6 metabolizers as determined by genotyping.
Key exclusion criteria (9 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, dermatologic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- History of depression or other potential for increased suicidality with paroxetine.
- Family or personal medical history of prolonged QTc, congenital deafness or sudden death, or 12-lead ECG with QTc>450 msec.
- A positive urine drug screen, use of tobacco or nicotine-containing products, or regular alcohol consumption exceeding 14 drinks/ week for females or 21 drinks/week for men within prior 6 months.
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 |
|---|---|---|
| Period 1Subjects will receive a single 45 mg dose of PF-00299804 on Day 1 of Period 1. | Drug | DDI |
| Period 2Subjects will receive a single 30 mg tablet of paroxetine once daily for 3 days (Days 1 to 3). Then, subjects will be co-administered a 45 mg single dose of PF-00299804 plus a single dose of 30 mg paroxetine on Day 4. Single 30 mg doses of paroxetine will be administered once daily for 6 days (Days 5-10). | Drug | DDI |
Primary outcome
Plasma AUCinf of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
Time frame: 8 weeks
Plasma AUCt of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
Time frame: 8 weeks
Plasma Cmax of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
Time frame: 8 weeks
Plasma AUCinf of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
Time frame: 8 weeks
Plasma AUCt of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
Time frame: 8 weeks
Plasma Cmax of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
Time frame: 8 weeks
14 secondary outcomes
Plasma CL/F of PF-00299804 in EM without paroxetine.
Time frame: 8 weeks
Plasma Tmax of PF-00299804 in EM without paroxetine.
Time frame: 8 weeks
Plasma t1/2 of PF-00299804 in EM without paroxetine.
Time frame: 8 weeks
Plasma MRT of PF-00299804 in EM without paroxetine.
Time frame: 8 weeks
Plasma CL/F of PF-00299804 in EM with paroxetine.
Time frame: 8 weeks
Plasma Tmax of PF-00299804 in EM with paroxetine.
Time frame: 8 weeks
Plasma t1/2 of PF-00299804 in EM with paroxetine.
Time frame: 8 weeks
Plasma MRT of PF-00299804 in EM with paroxetine.
Time frame: 8 weeks
Plasma AUCinf of PF-05199265 in EMs when given alone (if levels permit).
Time frame: 8 weeks
Plasma AUCt of PF-05199265 in EMs when given alone (if levels permit).
Time frame: 8 weeks
Plasma Cmax of PF-05199265 in EMs when given alone (if levels permit).
Time frame: 8 weeks
Plasma Tmax of PF-05199265 in EMs when given in combination with paroxetine (if levels permit).
Time frame: 8 weeks
Plasma t1/2 of PF-05199265 in EMs when given in combination with paroxetine (if levels permit).
Time frame: 8 weeks
Overall safety profile as characterized by laboratory abnormalities, observed physical examination, vital signs, ECGs, and adverse event monitoring.
Time frame: 8 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 22 Jun 2012.
- 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 Period 1 and Period 2 in people with Healthy Volunteers, 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 5 inclusion and 9 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 22 Jun 2012. 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?
Plasma AUCinf of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers (time frame: 8 weeks). The study lists 6 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 22 Jun 2012.