Status:
COMPLETED
Multiple Rising Oral Dose Study of PG 760564 Administered Twice Daily to Healthy Male/Female Volunteers for 14 Days
Lead Sponsor:
Procter and Gamble
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 D...
Detailed Description
This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 D...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00791388
Start Date
August 1 2005
End Date
January 1 2006
Last Update
November 4 2011
Active Locations (1)
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1
Stuart I Harris, MD, PhD
Miami, Florida, United States, 33126