NCT01031186

Who might be able to join this trial:

• Your liver function blood test results (AST, ALT, alkaline phosphate, and bilirubin) must be at or below 1.5 times the normal upper limit.
• You must be considered healthy by an experienced doctor, based on your medical history, physical exam, lab tests, and heart monitoring.
• You must be male and between 18 and 65 years old (inclusive) when you sign the consent form.
• You must agree to use appropriate contraception from your first dose until 3 months after your last dose.
• You must weigh at least 50 kg (about 110 lbs) and have a BMI between 18 and 29.9 (inclusive).
• You must be able to read and sign a written consent form.
• Your heart's electrical activity (a specific measurement from an ECG) must be below 450 milliseconds (confirm with trial site).

Who may not be able to join:

• You have tested positive for Hepatitis B or Hepatitis C within the 3 months before screening.
• You have a current or long-term history of liver disease or known liver or bile duct problems.
• You test positive for alcohol or recreational drugs before the study begins.
• You test positive for HIV.
• You have regularly drunk more than 21 units of alcohol per week (or more than 3 units per day) in the 6 months before the study.
• You have taken part in another clinical trial and received an experimental drug within 30 days before the first dose (or longer, depending on the drug involved).
• You have been exposed to more than 4 new experimental substances in the 12 months before the first dose.
• You have taken prescription or over-the-counter medicines, vitamins, herbal products, or dietary supplements within 7–14 days before the first dose (unless the study doctor decides it is safe).
• You have a known allergy or sensitivity to the study medication or any other drug or substance that could make participation unsafe.
• Taking part in this study would mean donating more than 500 ml of blood within any 56-day period.
• You are unwilling or unable to follow the study procedures.
• You are not able to make your own legal or mental decisions.
• You have asthma or a history of asthma.
• You smoke, use tobacco or nicotine products, or your urine test shows signs of smoking within 6 months before screening.
• You have eaten red wine, Seville oranges, grapefruit, grapefruit juice, pummelos, or related citrus fruits within 7 days before the first dose.
• You have a history of any significant mental health condition.
• You have a history of suicidal behaviour or certain levels of suicidal thoughts in the last 6 months (confirm with trial site).
• You have a history of significant heart rhythm problems or other significant heart disease.

Important: Always verify eligibility with the trial site directly before applying.