Oral Testosterone for the Treatment of Hypogonadism in Males

The purpose of this study is to evaluate the pharmacokinetic (PK) parameters of testosterone after administration of TSX-002 (easy to swallow testosterone capsules) to hypogonadal men. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the PK parameters of the testosterone metabolite, dihydrotestosterone (DHT), as well as the safety and tolerability of TSX-002. The study consists of three (3) periods, for which TSX-002 will be taken orally at various doses. Study duration is approximately 9 weeks.

Inclusion criteria

• Symptomatic hypogonadal male subjects (Testosterone > 100 and <300 ng/dL, two separate 10 am samples one week apart),
• 18-70 years old,
• Willing and able to provide informed consent and to participate in all 3 periods of the study.
• BMI < 35 kg/m2.

Exclusion criteria

• Malabsorption conditions (e.g. history of cholecystectomy, Inflammatory Bowel Disease, Pancreatitis, Celiac disease, Sprue, Dumping syndrome, Bariatric surgery; Short bowel syndrome, Lactose intolerance);
• Alcoholics or substance abuse;
• Gastroparesis; IPSS (International Prostate Symptom score) > 19; PSA (prostate-specific antigen)> 4 ng/ml;
• Congestive Heart Failure, uncontrolled (NYHC >1);
• Uncontrolled sleep apnea;
• Topical or injectable testosterone replacement therapy (any kind including dehydroepiandrosterone (DHEA) and nutritional supplements) within past 4 weeks;
• Testopel excluded if within 2 years;
• Aveed excluded if within past 6 months;
• Hematocrit > 50.