HealthyPhase 1NCT01217918
Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult Subjects
A Phase 1 study testing 1 mg, 5 mg and 10 mg in people with Healthy, run by Pfizer at 2 sites in United States.
Trial summary
Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 1 mg, 5 mg and 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Feb 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 Volunteers
- Japanese
Who cannot join
- Subjects with clinically significant skin lesions
- Subjects with known tuberculosis infection
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
Culver City, California, 90232
Pfizer Investigational Site
Glendale, California, 91206
About this study
Official title: APhase 1, Placebo-Controlled, Randomized, Parallel Group, Subject- And Investigator-Blind, Sponsor-Open Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PH-797804 Following Multiple Escalating Oral Doses In Healthy Japanese Adult Subjects
Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days.
- Conditions
- Healthy
- Being tested
- 1 mg, 5 mg, 10 mg
- Keywords
- PH-797804, Japanese, Phase 1, multiple dose study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 mgDrug
1 mg or placebo a material sparing tablet per day for 10 days
5 mgDrug
5 mg or placebo as material sparing tablet per day for 10 days
10 mgDrug
10 mg or placebo as a material sparing tablet per day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | PH-797804 Receives: Drug: 1 mg |
| Cohort 2 | Experimental | PH-797804 Receives: Drug: 5 mg |
| Cohotr 3 | Experimental | PH-797804 Receives: Drug: 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities.
Measured: Day 1 to Follow-up
Mean change from baseline in vital signs (blood pressure and heart rate) measurements
Measured: Baseline to Follow-up
Mean change from baseline in 12-lead ECG parameters
Measured: Baseline to Follow-up
Plasma PH-797804 Cmax, Cmin, Cavg(ss), Tmax, AUC(0-last), AUC(0-inf), AUC(0-tau), t1/2, CL/F, Vz/F, Rac, and Rac, Cmax
Measured: Days 1 and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionFeb 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
- NCT01217918
- Sponsor's protocol ID
- A6631027
- Status last verified
- Feb 2011
- First submitted
- 7 Oct 2010
- Last updated
- 15 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APhase 1, Placebo-Controlled, Randomized, Parallel Group, Subject- And Investigator-Blind, Sponsor-Open Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PH-797804 Following Multiple Escalating Oral Doses In Healthy Japanese Adult Subjects
- ClinicalTrials.gov ID
- NCT01217918
- Acronym / sponsor ID
- A6631027
- Conditions
- Healthy
- Keywords
- PH-797804, Japanese, Phase 1, multiple dose study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 8 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.
Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: 1 mgPH-797804 |
| Cohort 2 | Experimental | Drug: 5 mgPH-797804 |
| Cohotr 3 | Experimental | Drug: 10 mgPH-797804 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Volunteers
- Japanese
Key exclusion criteria (2 listed)
- Subjects with clinically significant skin lesions
- Subjects with known tuberculosis infection
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 |
|---|---|---|
| 1 mg1 mg or placebo a material sparing tablet per day for 10 days | Drug | Cohort 1 |
| 5 mg5 mg or placebo as material sparing tablet per day for 10 days | Drug | Cohort 2 |
| 10 mg10 mg or placebo as a material sparing tablet per day for 10 days | Drug | Cohotr 3 |
Primary outcome
Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities.
Time frame: Day 1 to Follow-up
Mean change from baseline in vital signs (blood pressure and heart rate) measurements
Time frame: Baseline to Follow-up
Mean change from baseline in 12-lead ECG parameters
Time frame: Baseline to Follow-up
Plasma PH-797804 Cmax, Cmin, Cavg(ss), Tmax, AUC(0-last), AUC(0-inf), AUC(0-tau), t1/2, CL/F, Vz/F, Rac, and Rac, Cmax
Time frame: Days 1 and 10
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 15 Feb 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1 mg, 5 mg and 10 mg in people with Healthy, run by Pfizer at 2 sites 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 2 inclusion and 2 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 15 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities. (time frame: Day 1 to Follow-up). The study lists 4 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 15 Feb 2011.