Study to Evaluate Potential Food Effects

This study has been completed.
Sponsor:
Information provided by:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00791817
First received: November 13, 2008
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: PG-760564
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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:
  • Cmax [ Time Frame: over 12 hours ] [ Designated as safety issue: No ]
    Maximum plasma concentration after a single dose


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
Experimental: 200 mg PG 760564, Subjects Fasted
200 mg PG 760564, Subjects Fasted, single dose
Drug: PG-760564
200 mg capsule, single dose,fasted when dosed, duration is 4 days
Experimental: 200 mg PG 760564, Subjects Fed
200 mg PG 760564, Subjects Fed high fat meal
Drug: PG-760564
200 mg capsule, single dose,high fat diet when dosed, duration is 4 days

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: William S Aronstein, PhD, MD, Procter and Gamble Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00791817     History of Changes
Other Study ID Numbers: 2005046B
Study First Received: November 13, 2008
Results First Received: August 4, 2011
Last Updated: August 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Procter and Gamble:
pharmacokinetics study

ClinicalTrials.gov processed this record on September 18, 2014