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 primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Cohort A | Experimental | Each subjects in Cohort A will receive 2 single doses of PF-06291874 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-06291874 will be administered in Period 4 in the fed state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06291874 | Drug | PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 75 mg to 500 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0-72/dose | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] | 0-72/dose | |
| Maximum Observed Plasma Concentration (Cmax) | 0-72/dose | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0-72/dose | |
| Plasma Decay Half-Life (t1/2) | 0-72/dose | |
| Apparent Oral Clearance (CL/F) | 0-72/dose | |
| Apparent Volume of Distribution (Vz/F) | 0-72/dose |
Not provided
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 Investigational Site | New Haven | Connecticut | 06511 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000624434 | PF-06291874 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Other | Correspondingly, placebo doses will be administered as suspension. |
|
| D004700 | Endocrine System Diseases |