Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism

Exclusion Criteria

• •A subject will not be eligible for study participation if he meets any of the following criteria.
• •1. History of significant sensitivity or allergy to androgens, castor oil or product excipients.
• •2. Clinically significant findings in the prestudy examinations.
• •3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS score \> 19 points.
• •4. Body mass index (BMI) ≥ 38 kg/m2.
• •5. Clinically significant abnormal laboratory values
• •6. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus antibodies (HIV Ab).
• •7. History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
• •8. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
• •9. History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration.
• •10. History of stroke or myocardial infarction within the past 5 years.
• •11. History of, or current or suspected, prostate or breast cancer.
• •12. History of diagnosed, severe, untreated, obstructive sleep apnea.
• •13. History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
• •14. History of long QT syndrome or unexplained sudden death in a first degree relative (parent, sibling, or child).
• •15. Concurrent treatment with medications which may impact the absorption, distribution, metabolism or excretion of testosterone undecanoate (TU) or place the subject at risk for treatment with testosterone.
• •16. Subject has a partner who is currently pregnant or planning pregnancy during the course of the clinical trial.