Study to Evaluate Potential Food Effects

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT00791817

Run by

Procter and Gamble

People needed

10

Starts

2005-08-01

Expected to finish

2006-01-01

Last updated by the study team

2011-09-07

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stuart I Harris, MD, PhD — Miami, Florida, United States

Full record on ClinicalTrials.gov

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