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Study to Evaluate Potential Food Effects
This study has been completed.
Sponsored by: Procter and Gamble
Information provided by: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00791817
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: PG-760564
Phase I

U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title: An Open-Label, Single Dose, Randomized, Crossover Study to Evaluate Potential Food Effects

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • An analysis of variance will be performed on PK parameters, i.e., logarithmic transformed AUC, AUCtlast, Cmax, etc. to detemine if there are any differences with a fasted and high fat meal on the absorption of PG 760564 [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2005
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Fasted Subjects
Drug: PG-760564
200 mg capsule, single dose,fasted when dosed, duration is 4 days
2: Experimental
Subjects on high fat meal
Drug: PG-760564
200 mg capsule, single dose,high fat diet when dosed, duration is 4 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791817

Locations
United States, Florida
Stuart I Harris, MD, PhD
Miami, Florida, United States, 33126
Sponsors and Collaborators
Procter and Gamble
Investigators
Study Director: William S Aronstein, MD, PhD Procter and Gamble
  More Information

Responsible Party: Procter and Gamble Pharmaceuticals ( William S Aronstein, PhD, MD )
Study ID Numbers: 2005046B
Study First Received: November 13, 2008
Last Updated: November 14, 2008
ClinicalTrials.gov Identifier: NCT00791817  
Health Authority: United States: Food and Drug Administration

Keywords provided by Procter and Gamble:
pharmacokinetics study

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on January 16, 2009