A Comparison Of The Pharmacokinetics Of PF-04191834 Following Single Dose Administration Of A Dispersion Formulation And A Suspension Formulation In Healthy Volunteers

Study Overview
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Brief Summary
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This study investigates the safety, tolerability and pharmacokinetics of PF-04191834 when respectively given orally as a single dispersion dose and a single dose of a suspension. The suspension is the test formulation and the dispersion is the formulation with which the novel preparation will be compared.

Official Title
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An Open Label, Randomized 3-Way Crossover Single Dose Study To Compare The Pharmacokinetics And Relative Bioavailability Of PF-04191834 Using An Oral Wet-Milled Suspension Formulation Versus An Oral Single Dose Dispersion Formulation Under Fasted Conditions In Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-04191834
* Drug: PF-04191834
* Drug: PF-04191834


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. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg(110 lbs). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). Clinical evidence of existing hepatic disease or a medical history of such a condition in the last year. Subjects with AST or ALT >ULN. Subjects with total bilirubin >ULN (except those with a documented history of Gilbert's Syndrome). Subjects with AST/ALT/total bilirubin >ULN and <1.5X ULN may be retested once. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication; Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day; Females of childbearing potential. Subjects with positive responses (score 1) for suicidality on the Sheehan Suicidality Tracking Scale (S-STS) (specifically items 1a, 1b, 3, 4, 5, 6, 7, or 9).

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 |
| --- | --- |
| Active Comparator: oral single dose dispersion 100mg<br>Subjects receive a single dose of PF-04191834 as a dispersion | Drug: PF-04191834<br>* single dose, 100mg, dispersion<br>|
| Active Comparator: oral wet milled suspension 100mg<br>Subjects receive a single dose of PF-04191834 as a suspension | Drug: PF-04191834<br>* single dose, 100mg, suspension<br>|
| Active Comparator: oral wet milled suspension 300mg<br>Subjects receive a single dose of PF-04191834 as a suspension | Drug: PF-04191834<br>* single dose, 300mg, suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of maximum concentration(Tmax) of PF-04191834 in plasma. |  | 3 days | 
| Area under the curve (AUClast) from the time of dosing to the last data point taken for PF-04191834. |  | 3 days | 
| Area under the curve from the time of dosing extrapolated to infinity(AUCinf) of PF-04191834. |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) for PF-04191834 in plasma. |  | 3 days | 
| Elimination half-life (t1/2) of PF-04191834 |  | 3 days | 
| Sheehan suicidality tracking scale (SSTS) |  | Screening and last Day of Period 3 | 
| Number of adverse events in patients as a measure of safety and tolerability. |  | Throughout the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, relative bioavailability, healthy volunteers, pharmacokinetics, suspension, dispersion