Study to Evaluate Potential Food Effects

• ClinicalTrials.gov Identifier: NCT00791817
• Recruitment Status: Completed
• First Posted: November 17, 2008
• Results First Posted: September 7, 2011
• Last Update Posted: September 7, 2011
• Sponsor: Procter and Gamble
• Information provided by: Procter and Gamble

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: PG-760564	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: An Open-label, Single Dose, Randomized, Crossover Study to Evaluate Potential Food Effects
• Study Start Date: August 2005
• Actual Primary Completion Date: January 2006
• Actual Study Completion Date: January 2006

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Cmax [ Time Frame: over 12 hours ]
   Maximum plasma concentration after a single dose

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• 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

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: William S Aronstein, PhD, MD, Procter and Gamble Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00791817
• Other Study ID Numbers: 2005046B
• First Posted: November 17, 2008
• Results First Posted: September 7, 2011
• Last Update Posted: September 7, 2011
• Last Verified: August 2011

Keywords provided by Procter and Gamble:

pharmacokinetics study