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
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the tolerability, safety and pharmacokinetics of PF-06650833 orally administered as modified release tablets in healthy Japanese subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300 mg | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06650833 | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing an AE/SAE | Day 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Day 1 and Day 10 | |
| Area under the plasma concentration time curve for dosing interval (AUCtau) | Day 1 and Day 10 | |
| Time to peak concentration |
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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000621967 | 1-(((2S,3S,4S)-3-ethyl-4-fluoro-5-oxopyrrolidin-2-yl)methoxy)-7-methoxyisoquinoline-6-carboxamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Day 1 and Day 10 |
| Clearance | Day 10 |
| Volume of distribution | Day 10 |
| Observed exposure accumulation ratio for AUCtau | Day 10 |
| Observed exposure accumulation ratio for Cmax | Day 10 |
| Minimum plasma concentration (Cmin) | Days 2, 4, 7 and 10 |
| Fluctuation ratio (Cmax:Cmin) | Day 10 |
| Mean residence time | Day 10 |
| change from baseline in vital signs | Day 18 |
| change form baseline in electrocardiogram (ECG) parameters | Day 18 |
| Incidence of treatment emergent clinical laboratory abnormalities | Day 18 |