HealthyPhase 1NCT01362673
PK And Safety Study Of PF-04171327 In Healthy Japanese And Western Subjects In Fasting And Fed Conditions
A Phase 1 study testing PF-04171327 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
This Phase 1 study is the first clinical trial in Japanese subjects. This study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-04171327 oral tablet in healthy adult Japanese and Western subjects in fasting and fed conditions. 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?
- PF-04171327
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 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 male and/or female subjects of non childbearing potential between the ages of 18 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- Japanese subjects who have four Japanese grandparents born in Japan.
Who cannot join
- Confirmed fasting glucose more than 100 mg/dL at Screening and Day 0 in both Cohort A and B.
- Corticosteroid use of more than 5 mg prednisone equivalent per day for more than 6 weeks.
- Evidence or history of clinically significant hematological (including anemia), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Glendale, California, 91206
About this study
Official title: A Phase 1, Randomized, Subject- And Investigator Blind, Sponsor Open, Placebo Controlled, Single- And Multiple-Dose Escalation Study Of PF-04171327 In Healthy Adult Japanese And Western Subjects In Fasting And Fed Conditions
This Phase 1 study is the first clinical trial in Japanese subjects. This study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-04171327 oral tablet in healthy adult Japanese and Western subjects in fasting and fed conditions.
- Conditions
- Healthy
- Being tested
- PF-04171327, Placebo
- Keywords
- Phase 1, Pharmacokinetics, food effect, Healthy Japanese, rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04171327Drug
Oral single 5 mg dose as one 5 mg tablet
PF-04171327Drug
Oral single 10 mg dose as one 10 mg tablet
PF-04171327Drug
Oral single 30 mg dose as three 10 mg tablets
PlaceboDrug
Oral single dose as matching placebo
PF-04171327Drug
Oral multiple 20 mg doses as two 10 mg tablets for 12 days
PlaceboDrug
Oral multiple doses as matching placebo for 12 days
| Study group | Role | What they receive |
|---|---|---|
| Single dose | Experimental | Not described Receives: Drug: PF-04171327; Drug: Placebo |
| Multiple dose | Experimental | Not described Receives: Drug: PF-04171327; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma pharmacokinetic parameters for PF-00251802 : Cmax
Measured: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802 : Tmax
Measured: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF00251802 : AUC(0-last)
Measured: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802 : As data permit AUC(0-inf)
Measured: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802 : As data permit t1/2
Measured: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax
Measured: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax
Measured: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUC(0-last)
Measured: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit AUC(0-inf)
Measured: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2
Measured: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802: Cmax for Day 1 and Day 12
Measured: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: Tmax for Day 1 and Day 12
Measured: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: AUCtau for Day 1 and Day 12
Measured: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: As data permit t1/2 for Day12
Measured: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12
Measured: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: Ctrough
Measured: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax for Day 1 and Day 12
Measured: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax for Day 1 and Day 12
Measured: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUCtau for Day 1 and Day 12
Measured: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2 for Day12
Measured: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12
Measured: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Ctrough
Measured: Day 1 to Day 15 in Cohort B
Secondary outcomes (2)
Biomarkers for bone effects: Serum procollagen type 1 N-terminal propeptide (P1NP), serum C terminal telopeptide of type I collagen (CTX), serum osteocalcin and urine N terminal telopeptide of type I collagen (uNTX).
Measured: Day 0 to Day 15 in Cohort B
Biomarkers for carbohydrate and metabolic: Plasma cortisol, serum glucose, plasma insulin and serum adiponectin.
Measured: Day 0 to Day 15 in Cohort B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2011
- Study completionAug 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 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
- NCT01362673
- Sponsor's protocol ID
- A9391012
- Status last verified
- Oct 2011
- First submitted
- 17 May 2011
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Subject- And Investigator Blind, Sponsor Open, Placebo Controlled, Single- And Multiple-Dose Escalation Study Of PF-04171327 In Healthy Adult Japanese And Western Subjects In Fasting And Fed Conditions
- ClinicalTrials.gov ID
- NCT01362673
- Acronym / sponsor ID
- A9391012
- Conditions
- Healthy
- Keywords
- Phase 1, Pharmacokinetics, food effect, Healthy Japanese, rheumatoid arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 May 2011 (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.
This Phase 1 study is the first clinical trial in Japanese subjects. This study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-04171327 oral tablet in healthy adult Japanese and Western subjects in fasting and fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose | Experimental | Drug: PF-04171327, Drug: Placebo |
| Multiple dose | Experimental | Drug: PF-04171327, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- Japanese subjects who have four Japanese grandparents born in Japan.
Key exclusion criteria (3 listed)
- Confirmed fasting glucose more than 100 mg/dL at Screening and Day 0 in both Cohort A and B.
- Corticosteroid use of more than 5 mg prednisone equivalent per day for more than 6 weeks.
- Evidence or history of clinically significant hematological (including anemia), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
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-04171327Oral single 5 mg dose as one 5 mg tablet | Drug | Single dose |
| PF-04171327Oral single 10 mg dose as one 10 mg tablet | Drug | Single dose |
| PF-04171327Oral single 30 mg dose as three 10 mg tablets | Drug | Single dose |
| PlaceboOral single dose as matching placebo | Drug | Single dose |
| PF-04171327Oral multiple 20 mg doses as two 10 mg tablets for 12 days | Drug | Multiple dose |
| PlaceboOral multiple doses as matching placebo for 12 days | Drug | Multiple dose |
Primary outcome
Plasma pharmacokinetic parameters for PF-00251802 : Cmax
Time frame: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802 : Tmax
Time frame: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF00251802 : AUC(0-last)
Time frame: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802 : As data permit AUC(0-inf)
Time frame: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802 : As data permit t1/2
Time frame: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax
Time frame: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax
Time frame: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUC(0-last)
Time frame: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit AUC(0-inf)
Time frame: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2
Time frame: Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802: Cmax for Day 1 and Day 12
Time frame: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: Tmax for Day 1 and Day 12
Time frame: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: AUCtau for Day 1 and Day 12
Time frame: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: As data permit t1/2 for Day12
Time frame: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12
Time frame: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: Ctrough
Time frame: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax for Day 1 and Day 12
Time frame: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax for Day 1 and Day 12
Time frame: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUCtau for Day 1 and Day 12
Time frame: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2 for Day12
Time frame: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12
Time frame: Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Ctrough
Time frame: Day 1 to Day 15 in Cohort B
2 secondary outcomes
Biomarkers for bone effects: Serum procollagen type 1 N-terminal propeptide (P1NP), serum C terminal telopeptide of type I collagen (CTX), serum osteocalcin and urine N terminal telopeptide of type I collagen (uNTX).
Time frame: Day 0 to Day 15 in Cohort B
Biomarkers for carbohydrate and metabolic: Plasma cortisol, serum glucose, plasma insulin and serum adiponectin.
Time frame: Day 0 to Day 15 in Cohort B
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 7 Oct 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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-04171327 in people with Healthy, run by Pfizer at 1 site 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 3 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: finished, as of the sponsor's last update on 7 Oct 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 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?
Plasma pharmacokinetic parameters for PF-00251802 : Cmax (time frame: Day 1 to Day 4 in each period of Cohort A). The study lists 22 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 7 Oct 2011.