A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Exclusion Criteria

• •1. Received oral topical, intranasal, or buccal T therapy within the previous 2 weeks, intramuscular T injection of short-acting duration within the previous 4 weeks, intramuscular T injection of long-acting duration within the previous 20 weeks, or T implantable pellets within the previous 6 months.
• •2. Received oral TU in a previous Clarus-sponsored investigational study.
• •3. Significant intercurrent disease of any type; in particular, liver, kidney, uncontrolled or poorly controlled heart disease, including hypertension, congestive heart failure or coronary heart disease, or psychiatric-illness, including severe depression.
• •4. Recent (within 2 years) history of stroke, transient ischemic attack, or acute coronary event.
• •5. A mean of the triplicate assessment of systolic blood pressure (sBP) \> 150 mm Hg and/or diastolic blood pressure (dBP) \> 90 mm Hg at screening.
• •6. Recent (within 2 years) history of angina or stent (coronary or carotid) placement.
• •7. Untreated, severe obstructive sleep apnea.
• •8. Clinically significant abnormal laboratory values (serum transaminases \> 2 × ULN, serum bilirubin \> 1.5 × ULN and serum creatinine \> 1.5 × ULN).
• •9. Hematocrit (HCT) value of \< 35% or \> 48%.
• •10. Has a history of polycythemia, either idiopathic or associated with testosterone replacement therapy (TRT).
• •11. Glycosylated hemoglobin (A1C) \> 8.5%.
• •12. BMI ≥ 38 kg/m2.
• •13. If receiving the following medications:
• •* Has been on stable doses of lipid-lowering medication for \< 3 months;
• •* Has been on stable doses of oral medication for diabetes for \< 2 months; or
• •* Has been on stable doses of antihypertensive medication for \< 3 months.
• •14. Abnormal prostate digital rectal examination (palpable nodules), elevated Prostate Specific Antigen (serum PSA \> 4.0 ng/mL), International Prostate Symptom Score (I-PSS) \> 19 points at screening, and/or history of, or current or suspected, prostate cancer.
• •15. History of, or current or suspected, breast cancer.
• •16. History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation within the previous 2 years.
• •17. 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.
• •18. Known malabsorption syndrome and/or current treatment with oral lipase inhibitors and bile acid-binding resins.
• •19. Inability to refrain from smoking during the confinement periods as required by the individual study center.
• •20. History of alcohol abuse or any drug substance within the previous 2 years.
• •21. Poor compliance or unlikely to keep clinic appointments.
• •22. Has received any drug as part of another research study within 30 days of initial dose administration in this study.
• •23. Donated blood (≥ 500 mL) within the 12-week period before the initial study dose.
• •24. Currently uses antiandrogens, 5-alpha-reductase inhibitors, estrogens, potent oral CYP3A4 inducers, potent CYP3A4 inhibitors, or long acting opioid analgesics.
• •25. Unwilling or unable to follow the dietary guidelines for this study, related to taking oral TU with meals that contain approximately 20 to 40 g of fat