Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Healthy adult males or females age ≥18 years of age with signed informed consent.
Women who are not post-menopausal or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment and who agree to use effective contraception for 30 days following the study.

Exclusion Criteria:

Clinically significant laboratory abnormalities,
Clinically significant abnormalities on physical examination,
BMI of less than 18 kg/m2 or greater than 32 kg/m2,
Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems,
History of seizures or epilepsy,
History of serious mental illness,
Participant in unrelated research involving investigational product within 30 days before planned date of drug administration,
Positive serology for HIV 1, HIV 2, HBsAg, or HCV,
Fever greater than 37.5°C at the time of planned dosing,
Suspicion of or recent history of alcohol or substance abuse,
Donated blood or blood products within the past 30 days,
Women who are pregnant or breastfeeding,
Employee or family member of the investigational site, and
Subjects who currently smoke cigarettes, cigars, pipes or chew tobacco products,

Subjects who are either unwilling to agree to refrain from use or found to be using:

Alcohol, caffeine, xanthine-containing food or beverages, nicotine products and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement period
Prescription medications from 14 days prior to and 7 days post treatment
Oral contraceptives without concomitant use of double-barrier contraceptives (condom, diaphragm with spermicide) for a period of 7 days prior to and 30 days post treatment