Subject selection.
anomaly, alcoholism, carnitine deficiency, psychiatric, allergic disease, drug abuse
HYPERSENSITIVITY REACTIONS, VIRUS, PROPIONIC ACIDEMIA, METHYLMALONIC ACIDURIA, CARNITINE TRANSPORTER DEFECT, HEPATITIS C, CARNITINE DEFICIENCY
Adult men or women 18 to 55 years of age were eligible if they had a body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/mSubjects were excluded for a history of any clinically significant medical or psychiatric condition that could interfere with the conduct of the study. In addition, subjects were excluded for a history or presence of alcoholism or drug abuse with the past 2 years; history of significant allergic disease or hypersensitivity reactions to study drug or related compounds; known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic acidemia); or any condition that could affect drug absorption. Subjects with positive urine drug or alcohol results at screening or the first study visit, or positive results for human immunodeficiency virus (HIV-1 and 2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at screening were excluded. Seated blood pressure < 90/40 mmHg or > 140/90 mmHg or heart rate <40 bpm or >99 bpm at the screening visit; QT interval corrected for heart rate using Fridericia’s formula (QTcF) interval >460 msec (males) or >470 msec (females) or abnormal clinically significant ECG findings at screening, were reasons for exclusion. Subjects had to have estimated creatinine clearance <80 mL/min at screening. Use of any prescription or non-prescription medications within 14 days; use of any drugs known to be significant inducers of cytochrome P450 (CYP) 2C19 or CYP3A4 enzymes and/or P-glycoprotein; or use of any gastric acid-reducing medications; valproic acid or divalproex sodium; probenecid; herbal products prior to the dosing, and throughout the study, was prohibited.