Study to Evaluate Potential Food Effects

Procter & Gamble (P&G)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: PG-760564

Study type

Interventional

Funder types

Industry

Identifiers

NCT00791817

2005046B

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.