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

Primary Purpose

Male Hypogonadism

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Oral testosterone undecanoate (containing 300 mg T)
Sponsored by
Clarus Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Hypogonadism focused on measuring Primary hypogonadism, Secondary hypogonadism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • LABiomedical Research Institute at Harbor-UCLA Medical Center
  • Anapharm, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Fasting (Treatment A)

Very low fat diet (Treatment B)

Low fat diet (Treatment C)

Normal diet (Treatment D)

High fat diet (Treatment E)

Arm Description

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

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 17, 2009
Last Updated
November 6, 2020
Sponsor
Clarus Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00924612
Brief Title
Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clarus Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Hypogonadism
Keywords
Primary hypogonadism, Secondary hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Open-label, five-period, randomized, four-sequence (ABCDE, BDCEA,CBEDA, DBAEC), cross-over study to determine the effect of food containing various amounts of dietary fat on the pharmacokinetics of oral TU.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fasting (Treatment A)
Arm Type
Experimental
Arm Description
Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state
Arm Title
Very low fat diet (Treatment B)
Arm Type
Experimental
Arm Description
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).
Arm Title
Low fat diet (Treatment C)
Arm Type
Experimental
Arm Description
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).
Arm Title
Normal diet (Treatment D)
Arm Type
Experimental
Arm Description
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).
Arm Title
High fat diet (Treatment E)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Oral testosterone undecanoate (containing 300 mg T)
Primary Outcome Measure Information:
Title
Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet
Description
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.
Time Frame
25 hour serial blood draws separated by 4 to 10 days of washout between treatments.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Swerdloff, MD
Organizational Affiliation
LABiomedical Research Institute at Harbor-UCLA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
LABiomedical Research Institute at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Anapharm, Inc.
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1P 0A2
Country
Canada

12. IPD Sharing Statement

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

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