Clinical Trial: Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: A Phase 1, Randomised, Open-label, 2-cohort, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Native Oral Testosterone Formulation (DITEST) in the Fed and Fasted State

Brief Summary: DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency in men. The proposed study is a Phase 1 clinical study in hypogonadal men, defined according to FDA and Endocrine Society Guidelines, designed to evaluate the pharmacokinetic (PK) characteristics of DITEST, and to assess the safety and tolerability of DITEST in the target population.