Safety and PK of MBX-400 (Cyclopropavir) in Normal Volunteers

Who cannot join

• 1.Have had an acute illness and/or an oral temperature >100.4°F (38°C) within three days prior to drug dosing; 2.Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation; Including acute or chronic medical disease or condition, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this study. 3.Have a known allergy to the components of MBX-400 or placebo capsules (microcrystalline cellulose, gelatin, titanium dioxide); 4.Have a history of anaphylaxis or other serious adverse reactions to nucleoside analog medications; 5.Have an active malignancy or history of metastatic or hematologic malignancy; 6.Have clinically significant abnormal ECG at screening based on ECG reading by pre-defined study consulting cardiologist; Including: 1) conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS> / =120ms, PR> / =220ms, any second or third degree AV block, or QTc prolongation (>450ms); 2) significant repolarization (ST segment or T wave) abnormality; 3) significant atrial or ventricular arrhythmia; 4) frequent atrial or ventricular ectopy (e.g., frequent premature atrial contractions, 2 premature ventricular contractions in a row); 5) ST elevation consistent with ischemia; or 6) evidence of past or evolving myocardial infarction 7.Have known currently active HIV, CMV, hepatitis B or hepatitis C infection; 8.Have clinically significant anemia or bleeding disorder; 9.Have clinically significant gastrointestinal disorder including ulcer disease or conditions affecting absorption; 10.Have a blood pressure or heart rate that is a Grade > / =1; 11.Have a total White Blood Cell (WBC) count, Absolute Neutrophil Count (ANC), hemoglobin or platelet count that is a Grade > / =1 at screening; 12.Have a creatinine higher than the normal range at screening; 13.Have an Alanine Aminotransferase (ALT) or an Aspartate Aminotransferase (AST) > Upper Limit of Normal at screening; 14.Have PT or PTT that is a Grade > / =1 at screening; 15.Have any electrolyte level (sodium, potassium) that is a Grade > / =1 at screening; 16.Have a value higher than trace for glucose, hemoglobin and/or protein on urinalysis at screening; 17.Have ongoing drug abuse/dependence (including alcohol) or a history of this within five years of enrollment; 18.Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other major psychiatric diagnosis; 19.Have a history of hospitalization for psychiatric illness, suicide attempt, or confinement for danger to self or others, within the past 10 years; Subjects with a psychiatric disorder not meeting exclusion criteria, e.g., attention-deficit hyperactivity disorder, that is controlled for a minimum of 3 months may be enrolled as long as the investigator has determined that the subject's mental status will not compromise the subject's ability to comply with protocol. 20.Have donated blood within 30 days prior to Day 1 or plans to donate blood during the study; 21.Have taken any drug active against herpes viruses within 30 days prior to Day 1 including but not limited to: acyclovir, valacyclovir, famciclovir, penciclovir, ganciclovir and valganciclovir; 22.Use of any medication on a chronic basis; 23.Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages within 72 hours prior to Check-in (Day -1); 24. Are taking or have utilized any drugs within 3 days prior to Day 1; alcohol or tobacco within 3 days prior to Day 1; or are a chronic alcohol user; Concomitant medications, including prescription and over the counter medications as well as herbals, vitamins and supplements, are not allowed within 3 days prior to Day 1. Chronic alcohol user is defined as consuming 10 or more alcoholic drinks per week. 25.Urine cotinine level >150 ng/mL; 26.Have taken any investigational agents within 28 days of Day 1; 27.Have a positive urine drug screen.