Healthy VolunteersPhase 1NCT00918164
Evaluation Of The Relative Bioavailability Of PF-04457845 Tablet To Solution Formulation And Food Effect In Healthy Subjects
A Phase 1 study testing PF-04457845 in people with Healthy Volunteers, run by Pfizer at 1 site in Singapore.
Trial summary
The purpose of this study is to estimate the bioavailability of PF-04457845 tablets relative to solution and evaluate the effect of food (fasted vs. high fat meal) on the pharmacokinetics of an oral tablet formulation of PF-04457845 Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PF-04457845
- 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
- May 2009to Jul 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 subjects or healthy female subjects of non-child bearing potential. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete 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);
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial;
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures;
- Willing and able to consume a non-vegetarian high-fat meal.
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);
- History of febrile illness within 5 days prior to the first dose;
- Any condition possibly affecting drug absorption (eg, gastrectomy);
- A positive urine drug screen;
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 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 5 half-lives (or determined by the local requirement, whichever is longer) preceding the first dose of trial medication;
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- 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;
- Pregnant or nursing females and females of child-bearing potential;
- Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication;
- Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of trial medication. Other exceptions may be granted by a qualified member of Pfizer study management;
- Unwillingness to refrain from consumption of grapefruit/pomelo or grapefruit/pomelocontaining products from 7 days prior to the first dose of study medication until the completion of the follow-up visit.
- Blood donation of approximately 1 unit (~500 mL) within 56 days prior to dosing;
- Unwillingness or inability to comply with the Lifestyle guidelines;
- Subject is the Investigator or sub-Investigator, research assistant, pharmacist, study coordinator, other staff, or a relative of study personnel directly involved with the conduct of the study;
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Single Dose, Crossover Study To Evaluate The Relative Bioavailability Of PF-04457845 Tablet To Solution Formulation And To Assess Food Effect In Healthy Subjects
The purpose of this study is to estimate the bioavailability of PF-04457845 tablets relative to solution and evaluate the effect of food (fasted vs. high fat meal) on the pharmacokinetics of an oral tablet formulation of PF-04457845
- Conditions
- Healthy Volunteers
- Being tested
- PF-04457845
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04457845Drug
Single dose, 8 mg as oral tablet and solution formulation
| Study group | Role | What they receive |
|---|---|---|
| Healthy adult volunteers | Experimental | Standard Phase 1 normal healthy adult volunteers, age range 21-55 years and of either sex Receives: Drug: PF-04457845 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma pharmacokinetics
Measured: up to 96 hours post dose
Secondary outcomes (1)
Safety and toleration including adverse events, vital signs measurements, 12-lead ECGs, Physical examination findings, Blood and urine safety tests.
Measured: pre-dose to follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2009
- Study completionJul 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
- 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)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918164
- Sponsor's protocol ID
- B0541005
- Status last verified
- Jul 2009
- First submitted
- 5 May 2009
- Last updated
- 10 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Single Dose, Crossover Study To Evaluate The Relative Bioavailability Of PF-04457845 Tablet To Solution Formulation And To Assess Food Effect In Healthy Subjects
- ClinicalTrials.gov ID
- NCT00918164
- Acronym / sponsor ID
- B0541005
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Jun 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 purpose of this study is to estimate the bioavailability of PF-04457845 tablets relative to solution and evaluate the effect of food (fasted vs. high fat meal) on the pharmacokinetics of an oral tablet formulation of PF-04457845
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adult volunteers | Experimental | Drug: PF-04457845Standard Phase 1 normal healthy adult volunteers, age range 21-55 years and of either sex |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects or healthy female subjects of non-child bearing potential. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete 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);
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial;
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures;
- Willing and able to consume a non-vegetarian high-fat meal.
Key exclusion criteria (15 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);
- History of febrile illness within 5 days prior to the first dose;
- Any condition possibly affecting drug absorption (eg, gastrectomy);
- A positive urine drug screen;
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 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;
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 |
|---|---|---|
| PF-04457845Single dose, 8 mg as oral tablet and solution formulation | Drug | Healthy adult volunteers |
Primary outcome
Plasma pharmacokinetics
Time frame: up to 96 hours post dose
1 secondary outcome
Safety and toleration including adverse events, vital signs measurements, 12-lead ECGs, Physical examination findings, Blood and urine safety tests.
Time frame: pre-dose to follow up
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 10 Jul 2009.
- 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 PF-04457845 in people with Healthy Volunteers, 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 5 inclusion and 15 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 10 Jul 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 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 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 pharmacokinetics (time frame: up to 96 hours post dose). 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 10 Jul 2009.