A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)

Exclusion Criteria

• •Serum sodium level below the lower limit of the site's clinical laboratory normal range at the study qualification visit,
• •Clinically significant laboratory abnormalities as determined by the Principal Investigator at laboratory screening
• •Creatinine clearance calculated by the Cockcroft and Gault method calculated to be \<90 mL/min for males and \<80 mL/min for females
• •Clinically significant abnormalities on physical examination,
• •Body weight less than 60 or greater than 80 kg and a body mass index 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 history of epilepsy,
• •History of serious (Principal Investigator judgment) mental illness,
• •Participant in any research involving investigational product within 30 days before planned date of drug administration,
• •Positive serology for human immunodeficiency virus type 1 or 2, hepatitis B surface antigen, or hepatitis C,
• •Fever greater than 37.5°C at the time of planned dosing,
• •Suspicion, 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,
• •Subjects who currently smoke cigarettes, cigars, pipes or chew tobacco products or who have used any tobacco product in the 30 days prior to screening,
• •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, dose (excluding hormonal contraceptives)
• •Hormonal contraceptives without concomitant use of double-barrier contraceptives (condom, diaphragm with spermicide) for a period of 7 days prior to, and 30 days post, dose
• •Subjects having previous exposure to Bendavia