Conditions: Male Hypogonadism
Keywords: Primary hypogonadism Secondary hypogonadism
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 16
Healthy volunteers: no

Brief summary:
The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

Detailed description:
Pharmacokinetics will be evaluated after the following types of meals: very low fat, low fat, normal diet, high fat, and fasting. Subjects will have one dose of TU administered 30 minutes after the initiation of the meal.

Arms:
arm 1: Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state arm 2: Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with very low fat (6-10% fat). arm 3: Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with low fat (20% fat). arm 4: Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with normal fat (30% fat). arm 5: Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with high fat (50% fat).

Interventions: intervention 1: Oral testosterone undecanoate (containing 300 mg T)
Intervention descriptions: intervention 1: None

Protocol document: