Relative Bioavailability and Food Effect Study

Study Overview
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Brief Summary
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Initial studies have used a powder in capsule formulation of PH797804. In future studies an immediate release tablet will be used. The purpose of this study is to compare blood levels of PH797804 following an oral dose of the powder in capsule formulation and the tablet formulation. In addition the effect of food blood levels of PH797804 will be investigated

Official Title
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A Phase 1, Randomized, Open-Label, Single Dose, 4-Way Crossover Study In Healthy Volunteers To Assess The Relative Bioavailability Of The Oral Powder In Capsule (PIC) And An Immediate Release (IR) Film-Coated Tablet Of PH-797804 In The Fed And Fasted State

Conditions
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Pain

Intervention / Treatment
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* Drug: PH797804
* Drug: PH797804
* Drug: PH797804
* Drug: PH797804


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female subjects aged 21 to 55 years Healthy is defined as no clinical relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests Willing to use acceptable methods of contraception as outlined in the study protocol Body mass index between 18 to 30 kg/m2 Subjects who are willing and able to comply with the scheduled visits, treatment plan and other study procedures Exclusion Criteria: Subjects with evidence or history of clinically significant disease Pregnant or nursing females Females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to the first dose until day 15 of period 4 Subjects with conditions possibly affecting drug absorption (eg gastrectomy) A positive approved immunoassay/ELISA blood test for TB Subjects with a history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men Subjects who have use prescription or nonprescription drugs, vitamins and/or dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication Subjects who have been administered medications capable of inducing hepatic enzyme metabolism (eg barbiturates, rifampin, carbamazepine, phenytoin or primidone) within 14 days (or 5 half-lives of the inducing agent, whichever is longer) of day 1 or within 28 days of administration of St John's wort

Ages Eligible for Study
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Minimum Age: 21 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: One<br> | Drug: PH797804<br>* Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fasted state<br>|
| Experimental: Two<br> | Drug: PH797804<br>* Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fed state<br>|
| Experimental: Three<br> | Drug: PH797804<br>* Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fasted state<br>|
| Experimental: Four<br> | Drug: PH797804<br>* Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fed state<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of PH797804 up to 336 hours after dosing in each treatment period |  | 336 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of PH797804 in each treatment period up to 336 hours post-dose |  | 336 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relative Bioavailability Effect of food