HealthyPhase 1NCT01226693
A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804
A Phase 1 study testing PH-797804 material sparing tablet, PH-797804 Phase2b/3 with sodium lauryl sulphate and PH-797804 Phase2b/3 without sodium lauryl sulphate in people with Healthy, run by Pfizer at 1 site in Singapore.
Trial summary
There is no difference in the rate and extent of absorption of the material sparing tablet (MST), the Phase2b/3 formulation (P2b/3) with sodium lauryl sulphate (SLS) and the p2b/3 formulation without SLS. 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?
- PH-797804 material sparing tablet, PH-797804 Phase2b/3 with sodium lauryl sulphate and PH-797804 Phase2b/3 without sodium lauryl sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2010to Mar 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects of non-childbearing potential between the ages of 21 and 55.
- No evidence of active or latent TB.
- An informed consent document signed and dated by the subject.
Who cannot join
- Evidence, including abnormal clinical laboratory parameters, eg, liver enzyme elevations, or a 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) or any active GI disease (including any relevant surgery).
- Any current and clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3. A clinically significant skin lesion is defined as Grade 1 (mild) for rash and pruritus, and Grade 2 (moderate) or above for all other lesions (see Short Name description in CTCAE for specific description of lesion).
- 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 study medication.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open Label, Single Dose, 3 Treatment, Two Period, Balanced Incomplete Block Study In Healthy Fasted Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of A 6 Mg Dose Of The PH-797804 Material Sparing Tablet (MST) And Two Modified Versions Of The MST Formulation With And Without The Solubilizing Agent Sodium Lauryl Sulphate (SLS)
There is no difference in the rate and extent of absorption of the material sparing tablet (MST), the Phase2b/3 formulation (P2b/3) with sodium lauryl sulphate (SLS) and the p2b/3 formulation without SLS.
- Conditions
- Healthy
- Being tested
- PH-797804 material sparing tablet, PH-797804 Phase2b/3 with sodium lauryl sulphate, PH-797804 Phase2b/3 without sodium lauryl sulphate
- Keywords
- pharmacokinetic, single dose bioequivalence study, balanced incomplete block design, PH-797804, P38 kinase inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH-797804 material sparing tabletDrug
oral, 6mg, single dose
PH-797804 Phase2b/3 with sodium lauryl sulphateDrug
oral, 6mg, single dose
PH-797804 Phase2b/3 with sodium lauryl sulphateDrug
oral, 6mg, single dose
PH-797804 material sparing tabletDrug
oral, 6mg, single dose
PH-797804 material sparing tabletDrug
oral, 6mg, single dose
PH-797804 Phase2b/3 without sodium lauryl sulphateDrug
oral, 6mg, single dose
PH-797804 Phase2b/3 without sodium lauryl sulphateDrug
oral, 6mg, single dose
PH-797804 material sparing tabletDrug
oral, 6mg, single dose
PH-797804 Phase2b/3 without sodium lauryl sulphateDrug
oral, 6mg, single dose
PH-797804 Phase2b/3 with sodium lauryl sulphateDrug
oral, 6mg, single dose
PH-797804 Phase2b/3 with sodium lauryl sulphateDrug
oral, 6mg, single dose
PH-797804 Phase2b/3 without sodium lauryl sulphateDrug
oral, 6mg, single dose
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Not described Receives: Drug: PH-797804 material sparing tablet; Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate |
| Sequence 2 | Experimental | Not described Receives: Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate; Drug: PH-797804 material sparing tablet |
| Sequence 3 | Experimental | Not described Receives: Drug: PH-797804 material sparing tablet; Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate |
| Sequence 4 | Experimental | Not described Receives: Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate; Drug: PH-797804 material sparing tablet |
| Sequence 5 | Experimental | oral, 6mg, single dose Receives: Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate; Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate |
| Sequence 6 | Experimental | oral, 6mg, single dose Receives: Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate; Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Measured: predose to day 7 of treatment period
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
Measured: predose to day 7 of treatment period
Maximum observed concentration within the dosing interval (Cmax)
Measured: predose to day 7 of treatment period
Time for Cmax (Tmax)
Measured: predose to day 7 of treatment period
Terminal half-life (t1/2)
Measured: predose to day 7 of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionMar 2011
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
- 18 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
- NCT01226693
- Sponsor's protocol ID
- A6631028
- Status last verified
- Mar 2011
- First submitted
- 20 Oct 2010
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open Label, Single Dose, 3 Treatment, Two Period, Balanced Incomplete Block Study In Healthy Fasted Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of A 6 Mg Dose Of The PH-797804 Material Sparing Tablet (MST) And Two Modified Versions Of The MST Formulation With And Without The Solubilizing Agent Sodium Lauryl Sulphate (SLS)
- ClinicalTrials.gov ID
- NCT01226693
- Acronym / sponsor ID
- A6631028
- Conditions
- Healthy
- Keywords
- pharmacokinetic, single dose bioequivalence study, balanced incomplete block design, PH-797804, P38 kinase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 Oct 2010 (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.
There is no difference in the rate and extent of absorption of the material sparing tablet (MST), the Phase2b/3 formulation (P2b/3) with sodium lauryl sulphate (SLS) and the p2b/3 formulation without SLS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: PH-797804 material sparing tablet, Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate |
| Sequence 2 | Experimental | Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate, Drug: PH-797804 material sparing tablet |
| Sequence 3 | Experimental | Drug: PH-797804 material sparing tablet, Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate |
| Sequence 4 | Experimental | Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate, Drug: PH-797804 material sparing tablet |
| Sequence 5 | Experimental | Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate, Drug: PH-797804 Phase2b/3 with sodium lauryl sulphateoral, 6mg, single dose |
| Sequence 6 | Experimental | Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate, Drug: PH-797804 Phase2b/3 without sodium lauryl sulphateoral, 6mg, single dose |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female subjects of non-childbearing potential between the ages of 21 and 55.
- No evidence of active or latent TB.
- An informed consent document signed and dated by the subject.
Key exclusion criteria (5 listed)
- Evidence, including abnormal clinical laboratory parameters, eg, liver enzyme elevations, or a 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) or any active GI disease (including any relevant surgery).
- Any current and clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3. A clinically significant skin lesion is defined as Grade 1 (mild) for rash and pruritus, and Grade 2 (moderate) or above for all other lesions (see Short Name description in CTCAE for specific description of lesion).
- 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 study medication.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
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 |
|---|---|---|
| PH-797804 material sparing tabletoral, 6mg, single dose | Drug | Sequence 1 |
| PH-797804 Phase2b/3 with sodium lauryl sulphateoral, 6mg, single dose | Drug | Sequence 1 |
| PH-797804 Phase2b/3 with sodium lauryl sulphateoral, 6mg, single dose | Drug | Sequence 2 |
| PH-797804 material sparing tabletoral, 6mg, single dose | Drug | Sequence 2 |
| PH-797804 material sparing tabletoral, 6mg, single dose | Drug | Sequence 3 |
| PH-797804 Phase2b/3 without sodium lauryl sulphateoral, 6mg, single dose | Drug | Sequence 3 |
| PH-797804 Phase2b/3 without sodium lauryl sulphateoral, 6mg, single dose | Drug | Sequence 4 |
| PH-797804 material sparing tabletoral, 6mg, single dose | Drug | Sequence 4 |
| PH-797804 Phase2b/3 without sodium lauryl sulphateoral, 6mg, single dose | Drug | Sequence 5 |
| PH-797804 Phase2b/3 with sodium lauryl sulphateoral, 6mg, single dose | Drug | Sequence 5 |
| PH-797804 Phase2b/3 with sodium lauryl sulphateoral, 6mg, single dose | Drug | Sequence 6 |
| PH-797804 Phase2b/3 without sodium lauryl sulphateoral, 6mg, single dose | Drug | Sequence 6 |
Primary outcome
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Time frame: predose to day 7 of treatment period
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: predose to day 7 of treatment period
Maximum observed concentration within the dosing interval (Cmax)
Time frame: predose to day 7 of treatment period
Time for Cmax (Tmax)
Time frame: predose to day 7 of treatment period
Terminal half-life (t1/2)
Time frame: predose to day 7 of treatment period
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 Mar 2011.
- 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 PH-797804 material sparing tablet, PH-797804 Phase2b/3 with sodium lauryl sulphate and PH-797804 Phase2b/3 without sodium lauryl sulphate 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 3 inclusion and 5 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 Mar 2011. 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?
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) (time frame: predose to day 7 of treatment period). The study lists 5 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 10 Mar 2011.