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

Phase 2

Completed

• Conditions: Male Hypogonadism
• Interventions: Drug: Oral testosterone undecanoate (containing 300 mg T)

• Registration Number: NCT00924612
• Lead Sponsor: Clarus Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-19
• Study Start: 2009-07
• Primary Completion: 2009-09
• Study Completion: 2010-07
• Disposition First Submitted: 2010-08-17
• Disposition First Submitted QC: 2010-08-17
• Disposition First Posted: 2010-08-19
• Results First Submitted: 2020-10-01
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-06
• Last Update Submitted: 2020-11-06
• Results First Posted: 2020-12-02
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Very low fat diet (Treatment B)	Oral testosterone undecanoate (containing 300 mg T)	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).
Fasting (Treatment A)	Oral testosterone undecanoate (containing 300 mg T)	Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state
Low fat diet (Treatment C)	Oral testosterone undecanoate (containing 300 mg T)	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).
Normal diet (Treatment D)	Oral testosterone undecanoate (containing 300 mg T)	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).
High fat diet (Treatment E)	Oral testosterone undecanoate (containing 300 mg T)	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).

Primary Outcome Measures

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

Trial Locations

Locations (2)

LABiomedical Research Institute at Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

Anapharm, Inc.; 🇨🇦 Quebec City, Quebec, Canada