Study to Evaluate Potential Food Effects

An Open-label, Single Dose, Randomized, Crossover Study to Evaluate Potential Food Effects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PG-760564; Drug: PG-760564

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Stuart I Harris, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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; Drug: PG-760564; 200 mg capsule, single dose,high fat diet 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,fasted when dosed, duration is 4 days; Drug: PG-760564; 200 mg capsule, single dose,high fat diet when dosed, duration is 4 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentration after a single dose	over 12 hours

Collaborators and Investigators

• Sponsor: Procter and Gamble
• Investigators: Study Director: William S Aronstein, MD, PhD, Procter and Gamble

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): January 1, 2006
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: November 13, 2008
• First Submitted That Met QC Criteria: November 14, 2008
• First Posted (Estimate): November 17, 2008

Study Record Updates

• Last Update Posted (Estimate): September 7, 2011
• Last Update Submitted That Met QC Criteria: August 4, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: pharmacokinetics study
• Other Study ID Numbers: 2005046B