The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate

Inclusion Criteria

• Man 18 to 65 years of age, inclusive, with a clinical diagnosis of hypogonadism (signs/symptoms consistent with hypogonadism for testosterone naïve subjects and history of signs/symptoms for subjects who have received prior treatment) as well as testosterone levels consistent with hypogonadism as defined by 2 morning total T values of 150 mm Hg and/or dBP > 90 mm Hg at screening (if prescribed antihypertensives, subject should be taking medications on the day of the screening visit with a sip of water). Subjects 140 mm Hg and/or dBP > 90 mm Hg at screening.
• Has had recent (within 2 years) history of angina or stent (coronary or carotid) placement.
• Has untreated, severe obstructive sleep apnea.
• Has clinically significant abnormal laboratory values, including serum transaminases > 2 × upper limits of normal (ULN), serum bilirubin > 1.5 × ULN and serum creatinine > 1.5 × ULN.
• Has a hematocrit (HCT) value of 48%.
• Has a history of polycythemia, either idiopathic or associated with TRT treatment.
• Is a diabetic subject with a glycosylated hemoglobin > 8.5%.
• Has a body mass index (BMI) ≥ 38 kg/m2.
• Has been on stable doses of antihypertensive medication for 4.0 ng/mL), I-PSS > 19 points at screening, and/or history of, or current or suspected, prostate cancer.
• Has a history of, or current or suspected, breast cancer.
• Has a history of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation within the previous 2 years.
• Use of dietary supplements such as saw palmetto or phytoestrogens and any dietary supplements that may increase total T, such as androstenedione or dehydroepiandrosterone within the previous 4 weeks.
• Has known malabsorption syndrome and/or current treatment with oral lipase inhibitors (eg, orlistat [Xenical®]) and/or bile acid-binding resins (eg, cholestyramine [Questran®], colestipol [Colestid®]) or treatments that promote gastric emptying (eg, metoclopramide [Reglan®]).
• Inability to observe all rules and smoking restrictions in place at the clinical facility during confinement.
• Has history of abuse of alcohol or any drug substance within the previous 2 years.
• Poor compliance or unlikely to keep clinic appointments and remain for entire confinement period.
• Has received any drug as part of another research study within 30 days of initial dose administration in this study.
• Donated blood (≥ 500 mL) within the 12-week period before the initial study dose.
• Current use of the following groups of drugs that effect T levels, T metabolism or levels of T metabolites, namely antiandrogens, 5-alpha-reductase inhibitors (eg, dutasteride, finasteride), estrogens, long-acting opioid analgesics (eg, methadone hydrochloride, buprenorphine hydrochloride) or human growth hormone (HGH).
• Unwilling or unable to follow the dietary requirements for this study.