Evaluating the Safety and Plasma Levels of N-Methanocarbathymidine (N-MCT) in Normal Patients

Exclusion Criteria

• •1. Medical conditions that preclude participation in the study as determined by the study physician investigators.
• •Note: Condition that may preclude participation includes:
• •1.1. Vital signs that are outside the ranges in the table below, measured after at least 10 minutes rest:
• •Blood Pressure (BP) 90-140/55-90 mmHg Pulse Rate (PR) 50 100 beats/min Tympanic Temperature (T) less than or equal to 37.6ºC Respiration Rate (RR) 12 to 20 breaths/minute
• •1.2. Current diagnosis of pulmonary disease 1.3. Current diagnosis of asthma, which has required use of asthma medications within the past year 1.4. History of or current diagnosis of diabetes mellitus 1.5. Autoimmune disorder, such as systemic lupus erythematosus, Wegener's granulomatosis, rheumatoid arthritis 1.6. History of malignancy except low-grade skin cancer (i.e., basal cell carcinoma which has been surgically cured) 1.7. Chronic renal, hepatic, or pulmonary disease or gastrointestinal tract condition that could interfere with the absorption of the study drug (e.g., surgical resection of significant proportions of the stomach or bowel, gastric bypass, gastric banding, cholecystectomy, irritable bowel syndrome, inflammatory bowel disease) 1.8. History of cardiac abnormalities including Wolff-Parkinson-White syndrome, dysrhythmias, or coronary artery disease 1.9. History of prolonged QT interval
• •2. Clinically significant abnormal electrocardiogram (ECG) at screening in the judgment of the investigator.
• •3. Screening laboratory values outside the acceptable low and upper limits unless deemed NCS by the principal investigator or sub-investigator.
• •4. Positive serology results for Hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) antibodies
• •5. Febrile illness with temperature documented \>38°C within 7 days of dosing
• •6. Pregnancy or breastfeeding
• •7. Known hypersensitivity or allergic reaction(s) to study drug components, including ingredients present in the formulation and/or to other nucleoside analogue antiviral drugs.
• •8. Have consumed any prohibited products or undergone any prohibited procedure listed in Table 3 within the indicated time frame.
• •9. Lack of ability to fully understand the informed consent. This will be determined by the recruiter/interviewer after explaining the consent and observing the subject reading the consent.
• •10. Use of any form of tobacco, including cigarette smoking, pipe smoking, oral tobacco, for 30 days before screening and for the duration of the study.
• •11. Any specific condition that, in the judgment of the Investigator, precludes participation because it could affect subject safety.