Status:
COMPLETED
Study to Evaluate Potential Food Effects
Lead Sponsor:
Procter and Gamble
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00791817
Start Date
August 1 2005
End Date
January 1 2006
Last Update
September 7 2011
Active Locations (1)
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1
Stuart I Harris, MD, PhD
Miami, Florida, United States, 33126