Study to Evaluate Potential Food Effects

Study Overview
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Brief Summary
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Half the group will be given a high fat diet and the other half will fast. They will then be crossed over.

Detailed Description
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A food-effect study which will be conducted at any time during the MRD study period on one single cohort of subjects using 200 mg oral dose of PG 760564. Half the group will be given a high fat diet and the other half will fast. They will ten be crossed over.

Official Title
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An Open-label, Single Dose, Randomized, Crossover Study to Evaluate Potential Food Effects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PG-760564
* Drug: PG-760564


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and surgically sterile or post-menopausal (last menstrual period > 1 year at the time of enrollment) healthy females, 18-45 years of age, inclusive, at screening; Who have not used tobacco or nicotine-containing products within the past 3 months; Willing to abstain from caffeine or xanthine-containing beverages, including coffee and tea, chocolate, alcohol, grapefruit juice, and Seville oranges, from 24 hours before admission and for the duration of the study; Who have a body mass index (BMI) between 18 and 32 kg/m2, inclusive. Exclusion Criteria: History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease; History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease; History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding; History of autoimmune disease; History of immunodeficiency or of unusual susceptibility to infectious diseases; History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV); Any history of hypersensitivity or clinically significant allergy to any drug; Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality; Family history of sudden death; History of uveitis or inflammatory ocular disease; History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding; History of autoimmune disease; History of immunodeficiency or of unusual susceptibility to infectious diseases; History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV); Any history of hypersensitivity or clinically significant allergy to any drug; Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality; Family history of sudden death; History of uveitis or inflammatory ocular disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200 mg PG 760564, Subjects Fasted<br>200 mg PG 760564, Subjects Fasted, single dose | Drug: PG-760564<br>* 200 mg capsule, single dose,fasted when dosed, duration is 4 days<br>|
| Experimental: 200 mg PG 760564, Subjects Fed<br>200 mg PG 760564, Subjects Fed high fat meal | Drug: PG-760564<br>* 200 mg capsule, single dose,high fat diet when dosed, duration is 4 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum plasma concentration after a single dose | over 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics study