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

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.

Study Overview

• Status: Completed
• Conditions: Male Hypogonadism
• Intervention / Treatment: Drug: Oral testosterone undecanoate (containing 300 mg T)

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Quebec City, Quebec, Canada, G1P 0A2
      • Anapharm, Inc.
• United States
  • California
    • Torrance, California, United States, 90502
      • LABiomedical Research Institute at Harbor-UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fasting (Treatment A); Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state	Drug: Oral testosterone undecanoate (containing 300 mg T)
EXPERIMENTAL: 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).	Drug: Oral testosterone undecanoate (containing 300 mg T)
EXPERIMENTAL: 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).	Drug: Oral testosterone undecanoate (containing 300 mg T)
EXPERIMENTAL: 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).	Drug: Oral testosterone undecanoate (containing 300 mg T)
EXPERIMENTAL: 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).	Drug: Oral testosterone undecanoate (containing 300 mg T)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Clarus Therapeutics, Inc.
• Investigators: Principal Investigator: Ronald Swerdloff, MD, LABiomedical Research Institute at Harbor-UCLA Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: June 17, 2009
• First Submitted That Met QC Criteria: June 18, 2009
• First Posted (ESTIMATE): June 19, 2009

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Secondary hypogonadism; Primary hypogonadism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: CLAR-09008