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

NCT ID: NCT00924612

Last Updated: 2020-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-07-31

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.

Conditions

Male Hypogonadism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fasting (Treatment A)

Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state

Group Type: EXPERIMENTAL

Oral testosterone undecanoate (containing 300 mg T)

Intervention Type: DRUG

Very low fat diet (Treatment B)

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).

Group Type: EXPERIMENTAL

Oral testosterone undecanoate (containing 300 mg T)

Intervention Type: DRUG

Low fat diet (Treatment C)

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).

Group Type: EXPERIMENTAL

Oral testosterone undecanoate (containing 300 mg T)

Intervention Type: DRUG

Normal diet (Treatment D)

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).

Group Type: EXPERIMENTAL

Oral testosterone undecanoate (containing 300 mg T)

Intervention Type: DRUG

High fat diet (Treatment E)

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).

Group Type: EXPERIMENTAL

Oral testosterone undecanoate (containing 300 mg T)

Intervention Type: DRUG

Interventions

Oral testosterone undecanoate (containing 300 mg T)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Clarus Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Swerdloff, MD

Role: PRINCIPAL_INVESTIGATOR

LABiomedical Research Institute at Harbor-UCLA Medical Center

Locations

LABiomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, United States

Anapharm, Inc.

Québec, Quebec, Canada

Countries

United States; Canada

Other Identifiers

CLAR-09008

Identifier Type: -

Identifier Source: org_study_id