Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002967-13 | EudraCT Number |
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
This study has been designed to investigate the effect of high fat food on the pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fasted condition | Other |
| |
| fed condition | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06372865 | Drug | 7.5 mg as 3 x 2.5 mg tablets single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). | basline to 48 hours |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | basline to 48 hours |
| Maximum Observed Plasma Concentration (Cmax) | basline to 48 hours | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | basline to 48 hours | |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | basline to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Systolic Blood Pressure | Value at time T minus value at baseline. | basline to 48 hours |
| Change from Baseline in Diastolic Blood Pressure | Value at time T minus value at baseline. |
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 |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| C000630159 | PF-06372865 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PF-06372865 |
| Drug |
7.5 mg as 3 x 2.5 mg tablets single dose |
|
| basline to 48 hours |
| Change from baseline in heart rate | value at time T minus value at baseline | basline to 48 hours |