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This is a BA study comparing the bioavailability of two new capsule formulations and one solution formulation to the isethionate capsule used in phase 1 and 2 trials in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference | Active Comparator | This is the reference formulation |
|
| NF1 | Experimental | This is a test formulation |
|
| NF2 | Experimental | This is a test formulation |
|
| SOL | Experimental | This is a test formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-0332991 | Drug | isethionate hard capsule, 125 mg, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma AUCinf for PD-0332991 | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose | |
| Plasma Cmax for PD-0332991 | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma AUClast for PD-0332991 | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose | |
| Plasma Tmax for PD-0332991 | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose |
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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 Investigational Site | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C500026 | palbociclib |
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| PD-0332991 |
| Drug |
freebase hard capsule with a "small" particle size, 125 mg, single dose |
|
| PD-0332991 | Drug | freebase hard capsule with a "large" particle size, 125 mg, single dose |
|
| PD-0332991 | Drug | oral solution, 50 mg, single dose |
|
| Plasma t1/2 for PD-0332991 | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose |
| Plasma CL/F for PD-0332991 | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose |
| Plasma Vz/F for PD-0332991 | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose |
| Plasma AUClast for PF-05089326 | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose |
| Plasma AUCinf for PF-05089326 | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose |
| Plasma Cmax for PF-05089326 | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose |
| Plasma Tmax for PF-05089326 | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose |
| Plasma AUClast for PF 05089326 / PD-0332991 ratio if appropriate | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose |
| Plasma AUCinf for PF 05089326 / PD-0332991 ratio if appropriate | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose |
| Plasma Cmax for PF 05089326 / PD-0332991 ratio if appropriate | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose |
| Plasma Tmax for PF 05089326 / PD-0332991 ratio if appropriate | 0 hour/predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours post dose |
| D017437 |
| Skin and Connective Tissue Diseases |