Study Investigating the Pharmacokinetic Interaction Between INX-08189 and Verapamil HCL ER in Healthy Volunteers

Exclusion Criteria

• •Subjects must NOT meet the following criteria at the Screening Visit (Visit1), in order to be eligible for study drug administration at Visit 2:
• •1. Infection with Hepatitis A, B or C Virus;
• •2. Infection with the Human Immunodeficiency Virus (HIV);
• •3. History of or any current medical condition which could impact the safety of the participant in the study;
• •4. Current active or underlying GI, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease;
• •5. Clinically significant abnormalities on centrally read ECG including evidence of bradycardia (rate \< 60 bpm) or evidence of PR prolongation;
• •6. Screening vital signs representing a heart rate of \< 60 bpm, systolic blood pressure \< 90 mm Hg, and diastolic blood pressure \< 60 mm Hg;
• •7. Currently significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability;
• •8. Safety laboratory abnormalities at screening which are clinically significant, or absolute neutrophil count of \< 1800 cells/mm3, or platelet count \< 130,000 cells/mm3, or hemoglobin \< 12 g/dl for women and \< 13 g/dl for men;
• •9. Women of child bearing potential, pregnant or breastfeeding;
• •10. Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding 2 years;
• •11. A positive urine drug test at screening;
• •12. Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 glass of beer, 1 glass of wine, 25ml shot of 40% spirit), consumption of alcohol 72 hours before or after study medication intake, consumption of an average of more than five (5) 240 ml servings of coffee or other caffeinated beverages per day;
• •13. Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications, including vitamins, within 7 days of starting the study;
• •14. Received an investigational drug or vaccine or used an investigational medical device within 3 months or 5 half lives (whichever is longer) before the planned start of treatment or having participated previously in a study with INX-08189;
• •15. Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study;
• •16. Consumption of grapefruit or grapefruit juice starting 48 hours before Study Day -1, during the subject's confinement in the unit, and during the outpatient follow-up periods.