Study to Evaluate Potential Food Effects

NCT ID: NCT00791817

Last Updated: 2011-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2006-01-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

200 mg PG 760564, Subjects Fasted

200 mg PG 760564, Subjects Fasted, single dose

Group Type: EXPERIMENTAL

PG-760564

Intervention Type: DRUG

200 mg capsule, single dose,fasted when dosed, duration is 4 days

200 mg PG 760564, Subjects Fed

200 mg PG 760564, Subjects Fed high fat meal

Group Type: EXPERIMENTAL

PG-760564

Intervention Type: DRUG

200 mg capsule, single dose,high fat diet when dosed, duration is 4 days

Interventions

PG-760564

200 mg capsule, single dose,fasted when dosed, duration is 4 days

Intervention Type: DRUG

PG-760564

200 mg capsule, single dose,high fat diet when dosed, duration is 4 days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Procter and Gamble Pharmaceuticals

Principal Investigators

William S Aronstein, MD, PhD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

Stuart I Harris, MD, PhD

Miami, Florida, United States

Countries

United States

Other Identifiers

2005046B

Identifier Type: -

Identifier Source: org_study_id