The Bioavailability of a Spray Dried Dispersion Solid Dose Formulation of PF-06260414 Relative to a Suspension Formulation

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Single-dose Open Label 3-way Crossover Study To Evaluate The Bioavailability Of A Spray Dried Dispersion Solid Dose Formulation Of Pf-06260414 Relative To A Suspension Formulation Under Fasted Conditions And The Effect Of Food On The Bioavailability Of The Pf-06260414 Spray Dried Dispersion Solid Formulation In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF 06260414 solid dose formulation
* Drug: PF-06260414 nanosuspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease Any condition possibly affecting drug absorption (eg, gastrectomy)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open label single dose crossover study of PF-06260414<br>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 | Drug: PF 06260414 solid dose formulation<br>* Single dose of 30 mg PF-06260414 given under fed/fasted conditions<br>Drug: PF-06260414 nanosuspension<br>* Single dose of 30 mg PF-06260414 given under fasted conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Tmax of PF-06260414 |  | Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease