Study to Evaluate Potential Food Effects

Phase 1

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
200 mg PG 760564, Subjects Fasted	PG-760564	200 mg PG 760564, Subjects Fasted, single dose
200 mg PG 760564, Subjects Fed	PG-760564	200 mg PG 760564, Subjects Fed high fat meal

Primary Outcome Measures