 a. Be sterile have had a vasectomy at least 6 months prior to Day 1 dosing and had sperm counts verifying that he is no longer fertile OR b. Agree he will not donate sperm during the study and for 3 months following the last dose of study medication, and c. Will strictly adhere to the following contraceptive measures for 3 months after the last dose of study medication: i. Abstain from sexual intercourse or; ii. Use a condom during sexual intercourse with a female of child-bearing potential. In addition to the male condom, the female partner must use another form of contraception e.g. intrauterine device IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal implants for at least 3 months following Day 1 dosing. 