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

NCT ID: NCT00924612

Last Updated: 2020-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Male Hypogonadism

Keywords

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Primary hypogonadism Secondary hypogonadism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fasting (Treatment A)

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

Group Type EXPERIMENTAL

Oral testosterone undecanoate (containing 300 mg T)

Intervention Type DRUG

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).

Group Type EXPERIMENTAL

Oral testosterone undecanoate (containing 300 mg T)

Intervention Type DRUG

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).

Group Type EXPERIMENTAL

Oral testosterone undecanoate (containing 300 mg T)

Intervention Type DRUG

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).

Group Type EXPERIMENTAL

Oral testosterone undecanoate (containing 300 mg T)

Intervention Type DRUG

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).

Group Type EXPERIMENTAL

Oral testosterone undecanoate (containing 300 mg T)

Intervention Type DRUG

Interventions

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Oral testosterone undecanoate (containing 300 mg T)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Clarus Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald Swerdloff, MD

Role: PRINCIPAL_INVESTIGATOR

LABiomedical Research Institute at Harbor-UCLA Medical Center

Locations

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LABiomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, United States

Site Status

Anapharm, Inc.

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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CLAR-09008

Identifier Type: -

Identifier Source: org_study_id