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Phlebotomy Study of Testosterone Undecanoate

Primary Purpose

Hypogonadism

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Oral Testosterone Undecanoate

About this trial

This is an interventional basic science trial for Hypogonadism

Eligibility Criteria

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

Inclusion Criteria:

Male, 18 to 65 years of age, inclusive, with a diagnosis of hypogonadism and a screening total serum T of < 300 ng/dL.
Adequate venous access to allow blood sample collections via venous cannula.
Naïve to androgen-replacement therapy or willing to temporarily cease current T treatment and willing to remain off all forms of T except for study medication throughout study.
Voluntarily provide written informed consent to participate in this study.

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria will not be eligible:

Significant intercurrent disease (especially liver, kidney, heart disease, uncontrolled diabetes mellitus or psychiatric illness)
Abnormal prostate digital rectal examination, elevated PSA (PSA > 4 ng/mL), AUA Symptom Score ≥ 15 points and/or history of prostate CA.
BMI less than 18 kg/m2 or greater than 37 kg/m2
Serum transaminases > 2 times upper limit of normal (ULN) or serum bilirubin >2.0 mg/dL.
History of severe or multiple allergies, or severe adverse drug reaction. A known hypersensitivity to lidocaine or all surgical dressings which may be used in the study procedures.
History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation.
Oral, topical or buccal T therapy within previous one week, or intramuscular T injection within previous 4 weeks.
Parenteral T-undecanoate therapy within the past 6 months.
Use of dietary supplements that may increase serum T, within previous 4 weeks.
Known malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile acid-binding resins, colestipol, fibric acid derivatives, clofibrate, gemfibrozil, and probucol.
Smokers unable to refrain from smoking during required confinement period.
History of, or current evidence of, abuse of alcohol or any drug substance.
Receipt of any research study drug within 30 days of study.
Blood donation within the 12 week period before the initial study dose.
Hematocrit less than 35% or greater than 50%.
History of clinically significant polycythemia following treatment with a testosterone replacement product.
Current use of paroxetine, clomipramine, antiandrogens, estrogens, potent P450 enzyme inducers, or barbiturates.
History of uncontrolled sleep apnea.

Sites / Locations

Los Angeles Biomedical Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral Testosterone Undecanoate

Arm Description

A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.

Outcomes

Primary Outcome Measures

% of Mean Difference in T Concentration Compared to Plain Collection Tube

The measured outcome presented is the difference as a percent of mean of T results when comparing T Concentrations measured in three different types of NaF containing collection tubes (NaF+EDTA, NaF+Oxalate and NaF) to T measured in blood collected in plain tubes. The % of Mean Difference in T concentration for each tube type was obtained by taking the average at each time point a T concentration was obtained, and calculating the mean difference between the test ((NaF+EDTA, NaF+Oxalate and NaF) tubes and the control (plain) tube. The concentration of total T will be determined in the serum/plasma samples of all subjects using validated LC/MS/MS methods at the Endocrine and Metabolic Research Lab.

Secondary Outcome Measures

Full Information

NCT ID

NCT02670343

First Posted

January 28, 2016

Last Updated

February 23, 2018

Sponsor

Clarus Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02670343

Brief Title

Phlebotomy Study of Testosterone Undecanoate

Official Title

Evaluation of Blood Collection Methodology Following Administration of a Single-Dose of an Oral Testosterone Undecanoate Formulation In Hypogonadal Men

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clarus Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a single study site. Each study participant received a single oral TU dose immediately prior to a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.

Detailed Description

This open-label, single oral dose, phlebotomy study was designed to clarify the issue of the influence of blood collection tubes on T, DHT, TU and DHTU measurements by collecting blood samples into various collection tubes from a small number of hypogonadal men dosed with a single oral TU dose in the form of a SEDDS formulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadism

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Testosterone Undecanoate

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Oral Testosterone Undecanoate

Other Intervention Name(s)

testosterone undecanoate

Intervention Description

Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.

Primary Outcome Measure Information:

Title

% of Mean Difference in T Concentration Compared to Plain Collection Tube

Description

Time Frame

Sample collection at -0.5, and 0 hours pre-dose and post-dose samples collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12, hours after a single dose of oral TU.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male, 18 to 65 years of age, inclusive, with a diagnosis of hypogonadism and a screening total serum T of < 300 ng/dL. Adequate venous access to allow blood sample collections via venous cannula. Naïve to androgen-replacement therapy or willing to temporarily cease current T treatment and willing to remain off all forms of T except for study medication throughout study. Voluntarily provide written informed consent to participate in this study. Exclusion Criteria: Subjects meeting any of the following exclusion criteria will not be eligible: Significant intercurrent disease (especially liver, kidney, heart disease, uncontrolled diabetes mellitus or psychiatric illness) Abnormal prostate digital rectal examination, elevated PSA (PSA > 4 ng/mL), AUA Symptom Score ≥ 15 points and/or history of prostate CA. BMI less than 18 kg/m2 or greater than 37 kg/m2 Serum transaminases > 2 times upper limit of normal (ULN) or serum bilirubin >2.0 mg/dL. History of severe or multiple allergies, or severe adverse drug reaction. A known hypersensitivity to lidocaine or all surgical dressings which may be used in the study procedures. History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation. Oral, topical or buccal T therapy within previous one week, or intramuscular T injection within previous 4 weeks. Parenteral T-undecanoate therapy within the past 6 months. Use of dietary supplements that may increase serum T, within previous 4 weeks. Known malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile acid-binding resins, colestipol, fibric acid derivatives, clofibrate, gemfibrozil, and probucol. Smokers unable to refrain from smoking during required confinement period. History of, or current evidence of, abuse of alcohol or any drug substance. Receipt of any research study drug within 30 days of study. Blood donation within the 12 week period before the initial study dose. Hematocrit less than 35% or greater than 50%. History of clinically significant polycythemia following treatment with a testosterone replacement product. Current use of paroxetine, clomipramine, antiandrogens, estrogens, potent P450 enzyme inducers, or barbiturates. History of uncontrolled sleep apnea.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christina Wang, M.D.

Organizational Affiliation

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Los Angeles Biomedical Research Institute

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Individual participant data will be provided to each respective investigator at the end of the trial.

Learn more about this trial

Phlebotomy Study of Testosterone Undecanoate

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