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

Male Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924612
• Other study ID #: CLAR-09008
• Status: Completed
• Phase: Phase 2
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: November 2020
• Source: Clarus Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male

• Age 18-65

• Morning serum testosterone (T) <300 ng/dL on two occasions

Exclusion Criteria:

• Significant intercurrent disease

• Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history of prostate cancer.

• Serum transaminases >2 times upper limit of normal

• Serum bilirubin >2.0 mg/dL

• Hematocrit <35% or >50%

• BMI >36

• Untreated, obstructive sleep apnea.

Related Conditions & MeSH terms

• Hypogonadism
• Male Hypogonadism

Intervention

Drug:
• Oral testosterone undecanoate (containing 300 mg T)

Locations

Country	Name	City	State
Canada	Anapharm, Inc.	Quebec City	Quebec
United States	LABiomedical Research Institute at Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Clarus Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet	PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25.	25 hour serial blood draws separated by 4 to 10 days of washout between treatments.