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

This study has been completed.
Sponsor:
Information provided by:
Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00924612
First received: June 17, 2009
Last updated: August 23, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Male Hypogonadism
Drug: Oral testosterone undecanoate (containing 300 mg of T)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Clarus Therapeutics, Inc.:

Primary Outcome Measures:
  • Serum testosterone Cmax [ Time Frame: 24-hour serial sampling following each of the treatment arms ] [ Designated as safety issue: Yes ]
  • Serum testosterone Cavg [ Time Frame: 24-hour serial sampling following each of the treatment arms ] [ Designated as safety issue: Yes ]
  • Serum testosterone Tmax [ Time Frame: 24-hour serial sampling following each of the treatment arms ] [ Designated as safety issue: No ]
  • Serum testosterone AUC [ Time Frame: 24-hour serial sampling following each of the treatment arms ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum DHT Cmax [ Time Frame: 24-hour serial sampling following each of the treatment arms ] [ Designated as safety issue: No ]
  • Serum DHT Cavg [ Time Frame: 24-hour serial sampling following each of the treatment arms ] [ Designated as safety issue: No ]
  • Serum DHT Tmax [ Time Frame: 24-hour serial sampling following each of the treatment arms ] [ Designated as safety issue: No ]
  • Serum DHT AUC [ Time Frame: 24-hour serial sampling following each of the treatment arms ] [ Designated as safety issue: No ]
  • Serum testosterone undecanoate (TU) Cmax [ Time Frame: 24-hour serial sampling following each of the treatment arms ] [ Designated as safety issue: No ]
  • Serum TU Tmax [ Time Frame: 24-hour serial sampling following each of the treatment arms ] [ Designated as safety issue: No ]
  • Serum TU AUC [ Time Frame: 24-hour serial sampling following each of the treatment arms ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: July 2009
Study Completion Date: July 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fasting Drug: Oral testosterone undecanoate (containing 300 mg of T)
Single dose administered orally, 30 minutes after the initiation of protocol-defined breakfast or while fasting, in each of the 5 arms.
Experimental: Very low fat diet Drug: Oral testosterone undecanoate (containing 300 mg of T)
Single dose administered orally, 30 minutes after the initiation of protocol-defined breakfast or while fasting, in each of the 5 arms.
Experimental: Low fat diet Drug: Oral testosterone undecanoate (containing 300 mg of T)
Single dose administered orally, 30 minutes after the initiation of protocol-defined breakfast or while fasting, in each of the 5 arms.
Experimental: Normal diet Drug: Oral testosterone undecanoate (containing 300 mg of T)
Single dose administered orally, 30 minutes after the initiation of protocol-defined breakfast or while fasting, in each of the 5 arms.
Experimental: High fat diet Drug: Oral testosterone undecanoate (containing 300 mg of T)
Single dose administered orally, 30 minutes after the initiation of protocol-defined breakfast or while fasting, in each of the 5 arms.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924612

Locations
United States, California
LABiomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Canada, Quebec
Anapharm, Inc.
Quebec City, Quebec, Canada, G1P 0A2
Sponsors and Collaborators
Clarus Therapeutics, Inc.
Investigators
Principal Investigator: Ronald Swerdloff, MD LABiomedical Research Institute at Harbor-UCLA Medical Center
  More Information

No publications provided

Responsible Party: Robert E. Dudley, PhD, Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00924612     History of Changes
Other Study ID Numbers: CLAR-09008
Study First Received: June 17, 2009
Last Updated: August 23, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Clarus Therapeutics, Inc.:
Primary hypogonadism
Secondary hypogonadism

Additional relevant MeSH terms:
Hypogonadism
Eunuchism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 28, 2014