A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects

Inclusion criteria

• Healthy men and post-menopausal (absence of periods for more than 2 years) surgically sterile, or non-pregnant, non-lactating women using a reliable form of contraception (see Inclusion Criteria 9)
• Age 18 to 65 years, inclusive
• Normal (no clinically significant abnormalities) laboratory tests (chemistry, hematology and urinalysis)
• No clinically significant abnormalities on ECG (QTcB interval must be < 450 ms)
• Weight ≥ 50kg and Body Mass Index (BMI) of 19 to 30, inclusive
• Negative urine drug screen at screening and on Study Day -1
• Negative serum βHCG pregnancy test at screening and on Study Day -1 (for all women)
• Hepatitis B surface antigen, hepatitis C antibody, and HIV antibody negative
• Agreement to practice a barrier method of birth control plus the use of a spermicide throughout the study period by both male and female subjects (oral contraceptives are not permitted)
• Able to complete all study visits
• Signed informed consent form (ICF)

Exclusion criteria

• Any active medical problem for which the subject is being evaluated and/or treated
• Calculated creatinine clearance (calculated using the IDMS traceable equation for the MDRD value) < 50 mL/min/1.73 m2
• Regular use of medications, prescription or non-prescription; no medication may be taken within 1 week prior to study dosing
• Use of alcohol within 48 hours prior to dosing (subjects must also agree to not use alcohol for 96 hours after dosing)
• Current lactation or breastfeeding
• Major surgery within 30 days prior to dosing
• Receipt of an investigational drug within 30 days prior to dosing
• Donation of blood or plasma within 30 days prior to dosing
• Any other problem, that in the opinion of the Investigator, will affect the safety of the subject or outcome of the study