Study to Evaluate Potential Food Effects

NCT00791817 | Completed Phase 1 Results

• 1 other identifier: 2005046B
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

pharmacokinetics study

Outcome Measures

Primary Outcomes (1)

• Cmax

  Maximum plasma concentration after a single dose

  over 12 hours

Study Arms (2)

200 mg PG 760564, Subjects Fasted

EXPERIMENTAL

200 mg PG 760564, Subjects Fasted, single dose

Drug: PG-760564

200 mg PG 760564, Subjects Fed

EXPERIMENTAL

200 mg PG 760564, Subjects Fed high fat meal

Drug: PG-760564

Interventions

PG-760564 DRUG

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

200 mg PG 760564, Subjects Fasted

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Stuart I Harris, MD, PhD

Miami, Florida, 33126, United States

Location

Results Point of Contact

• Title: Peter Thomas
• Organization: Procter & Gamble

thomas.pr@pg.com

513.622.4838

Study Officials

• William S Aronstein, MD, PhD

  Procter and Gamble

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 17, 2008
• Study Start: August 1, 2005
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: September 7, 2011
• Results First Posted: September 7, 2011

Record last verified: 2011-08

Locations

US (1)