Single Dose, Dose-Ranging Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men

Exclusion Criteria

• •1. Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
• •2. Men not living in the catchment area of the clinic or within a reasonable distance from the study site.
• •3. Clinically significant abnormal physical and laboratory findings at screening.
• •4. Elevated PSA (levels ≥ 2.5 ng/mL), according to local laboratory normal values.
• •5. Abnormal serum chemistry values, according to local laboratory reference ranges that indicate liver or kidney dysfunction or that may be considered clinically significant except for: an upper limit for fasting bilirubin less than 2 mg/dL, upper limit for cholesterol less than 221 mg/dL, or upper limit for fasting triglycerides less than 201 mg/dL.
• •6. Use of androgens within 2 months before first screening visit.
• •7. Ongoing use of body building nutritional supplements.
• •8. Systolic BP \> 135 mm Hg and Diastolic blood pressure BP \> 85 and mm Hg; ((BP) Blood pressure will be taken 3 times at 5 - minute intervals and the mean of all measurements be considered).
• •9. Clinically significant abnormal EKG or a QTc interval of \> 450 msec.
• •10. History of hypertension, including hypertension controlled with treatment.
• •11. Benign or malignant liver tumors; active liver disease.
• •12. History of breast carcinoma.
• •13. Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease.
• •14. Known history of cardiovascular, renal, hepatic or prostatic disease or significant psychiatric illness.
• •15. Positive serology for active Hepatitis (not immunization-related serology) or HIV at screening visit.
• •16. A serious systemic disease such as diabetes mellitus or obesity (body weight greater than BMI \>33 kg/m2 as above).
• •17. History of known, untreated sleep apnea.
• •18. Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones or study treatment compliance.
• •19. Partner is known to be pregnant.
• •20. Men desiring fertility within the first 24 weeks of study participation.
• •21. Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their sporting status.