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| ID | Type | Description | Link |
|---|---|---|---|
| SARM FOOD EFFECT & BE | Other Identifier | Alias Study Number | |
| SARM FOOD EFFECT &BE | Other Identifier | Alias Study Number |
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The current study will investigate the relative bioavailability of a spray dried dispersion solid dose formulation of PF 06260414 administered as a single oral dose of 30 mg of PF 06260414 relative to a single oral dose of 30 mg of PF 06260414 administered as a nanosuspension under fasted or fed conditions in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label single dose crossover study of PF-06260414 | Experimental | This will be a Phase 1, open label, randomized, single dose, 3 period, 3 way crossover study to evaluate the relative bioavailability of solid dose formulation of PF 06260414 under fasted conditions compared to the nanosuspension under fasted conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF 06260414 solid dose formulation | Drug | Single dose of 30 mg PF-06260414 given under fed/fasted conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Single dose pharmacokinetics under fasted condition: Cmax of PF- 06260414 formulations | Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose | |
| Single dose pharmacokinetics under fasted condition: AUClast of PF- 06260414 formulations | Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose | |
| Single dose pharmacokinetics under fed condition: Cmax of PF- 06260414 formulations | Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose | |
| Single dose pharmacokinetics under fed condition: AUClast of PF- 06260414 formulations | Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of PF-06260414 | Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose | |
| t½ of PF-06260414 | Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose | |
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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 New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| PF-06260414 nanosuspension | Drug | Single dose of 30 mg PF-06260414 given under fasted conditions |
|
| Tmax of PF-06260414 |
| Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |