Clinical trial NCT00791817: Study to Evaluate Potential Food Effects
Official title: An Open-label, Single Dose, Randomized, Crossover Study to Evaluate Potential Food Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics study
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2008-11-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax
timeFrame: over 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Stuart I Harris, MD, PhD
state: Florida
Study officials:
affiliation: Procter and Gamble
name: William S Aronstein, MD, PhD
role: STUDY_DIRECTOR
References: