Expired Study
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Miami, Florida 33126


Purpose:

The first portion will be a multiple rising dose (MRD) study assessing up to 4 cohorts of subjects, the last cohort being divided in 2 sub cohorts assessing the same dose of active drug vs. placebo.


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. Exclusion Criteria: - 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


NCT ID:

NCT00791388


Primary Contact:

Study Director
William S Aronstein, MD, PhD
Procter and Gamble


Backup Contact:

N/A


Location Contact:

Miami, Florida 33126
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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