PainPhase 1NCT00827515
Relative Bioavailability and Food Effect Study
A Phase 1 study testing PH797804 in people with Pain, run by Pfizer.
Trial summary
Initial studies have used a powder in capsule formulation of PH797804. In future studies an immediate release tablet will be used. The purpose of this study is to compare blood levels of PH797804 following an oral dose of the powder in capsule formulation and the tablet formulation. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- PH797804
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 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 or female subjects aged 21 to 55 years
- Healthy is defined as no clinical 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
- Willing to use acceptable methods of contraception as outlined in the study protocol
- Body mass index between 18 to 30 kg/m2
- Subjects who are willing and able to comply with the scheduled visits, treatment plan and other study procedures
Who cannot join
- Subjects with evidence or history of clinically significant disease
- Pregnant or nursing females
- Females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to the first dose until day 15 of period 4
- Subjects with conditions possibly affecting drug absorption (eg gastrectomy)
- A positive approved immunoassay/ELISA blood test for TB
- Subjects with a history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men
- Subjects who have use prescription or nonprescription drugs, vitamins and/or dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
- Subjects who have been administered medications capable of inducing hepatic enzyme metabolism (eg barbiturates, rifampin, carbamazepine, phenytoin or primidone) within 14 days (or 5 half-lives of the inducing agent, whichever is longer) of day 1 or within 28 days of administration of St John's wort
About this study
Official title: A Phase 1, Randomized, Open-Label, Single Dose, 4-Way Crossover Study In Healthy Volunteers To Assess The Relative Bioavailability Of The Oral Powder In Capsule (PIC) And An Immediate Release (IR) Film-Coated Tablet Of PH-797804 In The Fed And Fasted State
Initial studies have used a powder in capsule formulation of PH797804. In future studies an immediate release tablet will be used. The purpose of this study is to compare blood levels of PH797804 following an oral dose of the powder in capsule formulation and the tablet formulation. In addition the effect of food blood levels of PH797804 will be investigated
- Conditions
- Pain
- Being tested
- PH797804
- Keywords
- Relative Bioavailability Effect of food
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH797804Drug
Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fasted state
PH797804Drug
Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fed state
PH797804Drug
Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fasted state
PH797804Drug
Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fed state
| Study group | Role | What they receive |
|---|---|---|
| One | Experimental | Not described Receives: Drug: PH797804 |
| Two | Experimental | Not described Receives: Drug: PH797804 |
| Three | Experimental | Not described Receives: Drug: PH797804 |
| Four | Experimental | Not described Receives: Drug: PH797804 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of PH797804 up to 336 hours after dosing in each treatment period
Measured: 336 hours
Secondary outcomes (1)
Safety and tolerability of PH797804 in each treatment period up to 336 hours post-dose
Measured: 336 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 0 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
- NCT00827515
- Sponsor's protocol ID
- A6631025
- Status last verified
- Mar 2015
- First submitted
- 21 Jan 2009
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Single Dose, 4-Way Crossover Study In Healthy Volunteers To Assess The Relative Bioavailability Of The Oral Powder In Capsule (PIC) And An Immediate Release (IR) Film-Coated Tablet Of PH-797804 In The Fed And Fasted State
- ClinicalTrials.gov ID
- NCT00827515
- Acronym / sponsor ID
- A6631025
- Conditions
- Pain
- Keywords
- Relative Bioavailability Effect of food
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Apr 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 22 Jan 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.
Initial studies have used a powder in capsule formulation of PH797804. In future studies an immediate release tablet will be used. The purpose of this study is to compare blood levels of PH797804 following an oral dose of the powder in capsule formulation and the tablet formulation. In addition the effect of food blood levels of PH797804 will be investigated
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| One | Experimental | Drug: PH797804 |
| Two | Experimental | Drug: PH797804 |
| Three | Experimental | Drug: PH797804 |
| Four | Experimental | Drug: PH797804 |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects aged 21 to 55 years
- Healthy is defined as no clinical 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
- Willing to use acceptable methods of contraception as outlined in the study protocol
- Body mass index between 18 to 30 kg/m2
- Subjects who are willing and able to comply with the scheduled visits, treatment plan and other study procedures
Key exclusion criteria (8 listed)
- Subjects with evidence or history of clinically significant disease
- Pregnant or nursing females
- Females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to the first dose until day 15 of period 4
- Subjects with conditions possibly affecting drug absorption (eg gastrectomy)
- A positive approved immunoassay/ELISA blood test for TB
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 |
|---|---|---|
| PH797804Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fasted state | Drug | One |
| PH797804Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fed state | Drug | Two |
| PH797804Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fasted state | Drug | Three |
| PH797804Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fed state | Drug | Four |
Primary outcome
Blood levels of PH797804 up to 336 hours after dosing in each treatment period
Time frame: 336 hours
1 secondary outcome
Safety and tolerability of PH797804 in each treatment period up to 336 hours post-dose
Time frame: 336 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PH797804 in people with Pain, run by Pfizer.
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 8 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: withdrawn, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Blood levels of PH797804 up to 336 hours after dosing in each treatment period (time frame: 336 hours). 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 5 Mar 2015.