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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose | Experimental |
| |
| Multiple dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04171327 | Drug | Oral single 5 mg dose as one 5 mg tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetic parameters for PF-00251802 : Cmax | Day 1 to Day 4 in each period of Cohort A | |
| Plasma pharmacokinetic parameters for PF-00251802 : Tmax | Day 1 to Day 4 in each period of Cohort A | |
| Plasma pharmacokinetic parameters for PF00251802 : AUC(0-last) | Day 1 to Day 4 in each period of Cohort A | |
| Plasma pharmacokinetic parameters for PF-00251802 : As data permit AUC(0-inf) | Day 1 to Day 4 in each period of Cohort A | |
| Plasma pharmacokinetic parameters for PF-00251802 : As data permit t1/2 | Day 1 to Day 4 in each period of Cohort A | |
| Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax | Day 1 to Day 4 in each period of Cohort A | |
| Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax | Day 1 to Day 4 in each period of Cohort A | |
| Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUC(0-last) | 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) | Day 1 to Day 4 in each period of Cohort A | |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 0 to Day 15 in Cohort B | |
| Biomarkers for carbohydrate and metabolic: Plasma cortisol, serum glucose, plasma insulin and serum adiponectin. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Glendale | California | 91206 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000615597 | fosdagrocorat |
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| PF-04171327 |
| Drug |
Oral single 10 mg dose as one 10 mg tablet |
|
| PF-04171327 | Drug | Oral single 30 mg dose as three 10 mg tablets |
|
| Placebo | Drug | Oral single dose as matching placebo |
|
| PF-04171327 | Drug | Oral multiple 20 mg doses as two 10 mg tablets for 12 days |
|
| Placebo | Drug | Oral multiple doses as matching placebo for 12 days |
|
| Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2 |
| Day 1 to Day 4 in each period of Cohort A |
| Plasma pharmacokinetic parameters for PF-00251802: Cmax for Day 1 and Day 12 | Day 1 to Day 15 in Cohort B |
| Plasma pharmacokinetic parameters for PF-00251802: Tmax for Day 1 and Day 12 | Day 1 to Day 15 in Cohort B |
| Plasma pharmacokinetic parameters for PF-00251802: AUCtau for Day 1 and Day 12 | Day 1 to Day 15 in Cohort B |
| Plasma pharmacokinetic parameters for PF-00251802: As data permit t1/2 for Day12 | 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 | Day 1 to Day 15 in Cohort B |
| Plasma pharmacokinetic parameters for PF-00251802: Ctrough | Day 1 to Day 15 in Cohort B |
| Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax for Day 1 and Day 12 | Day 1 to Day 15 in Cohort B |
| Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax for Day 1 and Day 12 | Day 1 to Day 15 in Cohort B |
| Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUCtau for Day 1 and Day 12 | Day 1 to Day 15 in Cohort B |
| Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2 for Day12 | 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 | Day 1 to Day 15 in Cohort B |
| Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Ctrough | Day 1 to Day 15 in Cohort B |
| Day 0 to Day 15 in Cohort B |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |