Multiple Rising Oral Dose Study of PG 760564 Administered Twice Daily to Healthy Male/Female Volunteers for 14 Days
- Registration Number
- NCT00791388
- Lead Sponsor
- Procter and Gamble
- 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 Days (27 Doses).
- 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 Days (27 Doses). The study is a multiple rising dose (MRD) study of active drug vs. placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 400 mg PG 760564 PG-760564 400 mg PG 760564 active placebo Placebo placebo capsule 50 mg PG 760564 PG-760564 50 mg PG 760564 active 100 mg PG 760564 PG-760564 100 mg PG 760564 active 200 mg PG 760564 PG-760564 200 mg PG 760564 active
- Primary Outcome Measures
Name Time Method AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14 14 days the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours
Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14 12 hours on Day 14 Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14
Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14 12 Hours on Day 14 the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14
t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14 over a Dosing Interval (τ = 12 Hours) on Day 14 t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Stuart I Harris, MD, PhD
🇺🇸Miami, Florida, United States