Study to Evaluate Potential Food Effects
This study has been completed.
Sponsor:
Procter and Gamble
Information provided by:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00791817
First received: November 13, 2008
Last updated: August 4, 2011
Last verified: August 2011
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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
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 June 17, 2013