Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Procter and Gamble
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.
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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.
You may not be if
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;
