Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The current study is designed to evaluate the safety, tolerability and pharmacokinetics of PF-05221304 in healthy Japanese adult subjects following single and multiple dose administration.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A_Active | Experimental | 3 single doses treatment of PF-05221304 |
|
| Cohort B_Active | Experimental | Repeated doses of PF-05221304 |
|
| Cohort B_Placebo | Placebo Comparator | Repeated doses of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05221304 | Drug | 3, 10, 50 mg |
| |
| PF-05221304 |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast) | 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose | |
| Cohort A: Maximum observed plasma concentration (Cmax) | 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose | |
| Cohort A: Time to reach Cmax (Tmax) | 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose | |
| Cohort A: Area under the plasma concentration time profile from time zero extrapolated to infinite time (as data permit) (AUCinf) | 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose | |
| Cohort A: Terminal half life (as data permit) (t1/2) | 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose | |
| Cohort A: Apparent clearance (as data permit) (CL/F) | 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose | |
| Cohort A: Apparent volume of distribution (as data permit) (Vz/F) | 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose | |
| Cohort B: Number of Subjects experiencing an Adverse Event | Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG. | Screening up to 28 days after last dose of study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A: Number of Subjects experiencing an Adverse Event | Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG. | Screening up to 28 days after last dose of study medication |
| Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 1) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P-one Clinic, Keikokai Medical Corporation | Hachioji-shi | Tokyo | 192-0071 | Japan |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
50 mg multiple dose |
|
| Placebo | Drug | Placebo |
|
| 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose |
| Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 14) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose |
| Cohort B: Maximum plasma concentration during the dosing interval (Cmax)(Day 1) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose |
| Cohort B: Maximum plasma concentration during the dosing interval (Cmax)(Day 14) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose |
| Cohort B: Time to reach Cmax (Tmax)(Day 1) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose |
| Cohort B: Time to reach Cmax (Tmax)(Day 14) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose |
| Cohort B: Minimum plasma concentration during the dosing interval (Cmin)(Day 14) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose |
| Cohort B: Peak trough ratio (PTR)(Day 14) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose |
| Cohort B: Observed accumulation ratio (Rac)(Day 14) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose |
| Cohort B: Observed accumulation ratio for Cmax (Rac,Cmax)(Day 14) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose |
| Cohort B: Terminal half life (t1/2)(Day 14) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose |
| Cohort B: Apparent volume of distribution (Vz/F)(Day 14) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose |
| Cohort B: Apparent clearance (CL/F)(Day 14) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose |