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Completed

NCT Number: NCT00924612

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

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.

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Key information

Conditions

Male Hypogonadism Endocrine System Diseases Eunuchism Gonadal Disorders Hypogonadism

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Anapharm, Inc., Québec, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral testosterone undecanoate (containing 300 mg T)

Drug

Primary outcomes

  1. Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet

    Time frame: 25 hour serial blood draws separated by 4 to 10 days of washout between treatments.

    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.

Sponsors and collaborators

Lead sponsor

Clarus Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jun 19, 2009
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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