NCT02670343

Phlebotomy Study of Testosterone Undecanoate

Evaluation of Blood Collection Methodology Following Administration of a Single-Dose of an Oral Testosterone Undecanoate Formulation In Hypogonadal Men

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Clarus Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a single study site. Each study participant received a single oral TU dose immediately prior to a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.

Detailed description

This open-label, single oral dose, phlebotomy study was designed to clarify the issue of the influence of blood collection tubes on T, DHT, TU and DHTU measurements by collecting blood samples into various collection tubes from a small number of hypogonadal men dosed with a single oral TU dose in the form of a SEDDS formulation.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	Oral Testosterone Undecanoate	Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2016-02-01
• Last updated: 2018-03-09
• Results posted: 2018-03-09

Locations

1 site across 1 country: United States