NCT00924612

Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

Phase II Study of the Effect of Food With Various Levels of Fat on the Pharmacokinetics of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Clarus Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Male Hypogonadism

Interventions

Type	Name	Description
DRUG	Oral testosterone undecanoate (containing 300 mg T)

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-09-01
• Completion: 2010-07-01
• First posted: 2009-06-19
• Last updated: 2020-12-02
• Results posted: 2020-12-02

Locations

2 sites across 2 countries: United States, Canada