HealthyPhase 1NCT00857571
A Four-Way Cross-Over Study To Compare The Plasma Concentrations Of PF-02413873 After Oral Administration Of Several Doses As Suspension And As Tablets.
A Phase 1 study testing 150 mg Suspension, 30 mg Suspension and 400 mg Suspension in people with Healthy, run by Pfizer at 1 site in Singapore.
Trial summary
The study compares the plasma concentrations of PF-02413873 after administration of several doses as suspension and as tablets Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 150 mg Suspension, 30 mg Suspension and 400 mg Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2009to May 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers.
- Female volunteers have to be of non-childbearing potential
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Randomized Incomplete Block Four-Way Crossover Study To Evaluate The Dose Response Of PF-02413873 Tablets And PF-02413873 Suspension.
The study compares the plasma concentrations of PF-02413873 after administration of several doses as suspension and as tablets
- Conditions
- Healthy
- Being tested
- 150 mg Suspension, 30 mg Suspension, 400 mg Suspension, 5 mg Suspension, 750 mg Suspension
- Keywords
- Dose Response Bioavailability Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150 mg SuspensionDrug
Single oral dose of 150 mg of PF-02413873 suspension
30 mg SuspensionDrug
Single oral dose of 30 mg of PF-02413873 suspension
400 mg SuspensionDrug
Single oral dose of 400 mg of PF-02413873 suspension
5 mg SuspensionDrug
Single oral dose of 5 mg of PF-02413873 suspension
750 mg SuspensionDrug
Single oral dose of 750 mg of PF-02413873 suspension
150 mg TabletDrug
Single oral dose of 150 mg of PF-02413873 tablets
30 mg TabletDrug
Single oral dose of 30 mg of PF-02413873 tablets
400 mg TabletDrug
Single oral dose of 400 mg of PF-02413873 tablets
5 mg TabletDrug
Single oral dose of 5 mg of PF-02413873 tablets
750 mg TabletDrug
Single oral dose of 750 mg of PF-02413873 tablets
| Study group | Role | What they receive |
|---|---|---|
| Suspension | Experimental | PF-02413873 suspension Receives: Drug: 150 mg Suspension; Drug: 30 mg Suspension; Drug: 400 mg Suspension; Drug: 5 mg Suspension; Drug: 750 mg Suspension |
| Tablet | Experimental | PF-02413873 Phase 2 Tablets Receives: Drug: 150 mg Tablet; Drug: 30 mg Tablet; Drug: 400 mg Tablet; Drug: 5 mg Tablet; Drug: 750 mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Cmax, AUCinf
Measured: June - July 2009
Secondary outcomes (1)
Tmax, Tlag, AUClast, AUCt, t½, Frel.
Measured: June-July 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 12 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
- NCT00857571
- Sponsor's protocol ID
- B0461003
- Status last verified
- Dec 2018
- First submitted
- 5 Mar 2009
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Randomized Incomplete Block Four-Way Crossover Study To Evaluate The Dose Response Of PF-02413873 Tablets And PF-02413873 Suspension.
- ClinicalTrials.gov ID
- NCT00857571
- Acronym / sponsor ID
- B0461003
- Conditions
- Healthy
- Keywords
- Dose Response Bioavailability Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 6 Mar 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.
The study compares the plasma concentrations of PF-02413873 after administration of several doses as suspension and as tablets
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspension | Experimental | Drug: 150 mg Suspension, Drug: 30 mg Suspension, Drug: 400 mg Suspension, Drug: 5 mg Suspension, Drug: 750 mg SuspensionPF-02413873 suspension |
| Tablet | Experimental | Drug: 150 mg Tablet, Drug: 30 mg Tablet, Drug: 400 mg Tablet, Drug: 5 mg Tablet, Drug: 750 mg TabletPF-02413873 Phase 2 Tablets |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female volunteers.
- Female volunteers have to be of non-childbearing potential
Key exclusion criteria (3 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.
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 |
|---|---|---|
| 150 mg SuspensionSingle oral dose of 150 mg of PF-02413873 suspension | Drug | Suspension |
| 30 mg SuspensionSingle oral dose of 30 mg of PF-02413873 suspension | Drug | Suspension |
| 400 mg SuspensionSingle oral dose of 400 mg of PF-02413873 suspension | Drug | Suspension |
| 5 mg SuspensionSingle oral dose of 5 mg of PF-02413873 suspension | Drug | Suspension |
| 750 mg SuspensionSingle oral dose of 750 mg of PF-02413873 suspension | Drug | Suspension |
| 150 mg TabletSingle oral dose of 150 mg of PF-02413873 tablets | Drug | Tablet |
| 30 mg TabletSingle oral dose of 30 mg of PF-02413873 tablets | Drug | Tablet |
| 400 mg TabletSingle oral dose of 400 mg of PF-02413873 tablets | Drug | Tablet |
| 5 mg TabletSingle oral dose of 5 mg of PF-02413873 tablets | Drug | Tablet |
| 750 mg TabletSingle oral dose of 750 mg of PF-02413873 tablets | Drug | Tablet |
Primary outcome
Pharmacokinetics: Cmax, AUCinf
Time frame: June - July 2009
1 secondary outcome
Tmax, Tlag, AUClast, AUCt, t½, Frel.
Time frame: June-July 2009
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- 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 150 mg Suspension, 30 mg Suspension and 400 mg Suspension in people with Healthy, run by Pfizer at 1 site in Singapore.
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: stopped early, as of the sponsor's last update on 7 Dec 2018. 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 Singapore. 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 was stopped early. Results are not available in the source record.
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?
Pharmacokinetics: Cmax, AUCinf (time frame: June - July 2009). 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 Dec 2018.