Phlebotomy Study of Testosterone Undecanoate

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

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.

Study Overview

• Status: Completed
• Conditions: Hypogonadism
• Intervention / Treatment: Drug: Oral Testosterone Undecanoate

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90502
      • Los Angeles Biomedical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Male, 18 to 65 years of age, inclusive, with a diagnosis of hypogonadism and a screening total serum T of < 300 ng/dL.
2. Adequate venous access to allow blood sample collections via venous cannula.
3. 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.
4. Voluntarily provide written informed consent to participate in this study.

Exclusion Criteria:

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

1. Significant intercurrent disease (especially liver, kidney, heart disease, uncontrolled diabetes mellitus or psychiatric illness)
2. Abnormal prostate digital rectal examination, elevated PSA (PSA > 4 ng/mL), AUA Symptom Score ≥ 15 points and/or history of prostate CA.
3. BMI less than 18 kg/m2 or greater than 37 kg/m2
4. Serum transaminases > 2 times upper limit of normal (ULN) or serum bilirubin >2.0 mg/dL.
5. 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.
6. History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation.
7. Oral, topical or buccal T therapy within previous one week, or intramuscular T injection within previous 4 weeks.
8. Parenteral T-undecanoate therapy within the past 6 months.
9. Use of dietary supplements that may increase serum T, within previous 4 weeks.
10. Known malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile acid-binding resins, colestipol, fibric acid derivatives, clofibrate, gemfibrozil, and probucol.
11. Smokers unable to refrain from smoking during required confinement period.
12. History of, or current evidence of, abuse of alcohol or any drug substance.
13. Receipt of any research study drug within 30 days of study.
14. Blood donation within the 12 week period before the initial study dose.
15. Hematocrit less than 35% or greater than 50%.
16. History of clinically significant polycythemia following treatment with a testosterone replacement product.
17. Current use of paroxetine, clomipramine, antiandrogens, estrogens, potent P450 enzyme inducers, or barbiturates.
18. History of uncontrolled sleep apnea.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Testosterone Undecanoate; 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.	Drug: Oral Testosterone Undecanoate; Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.; Other Names: testosterone undecanoate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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.	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.

Collaborators and Investigators

• Sponsor: Clarus Therapeutics, Inc.
• Investigators: Principal Investigator: Christina Wang, M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: February 23, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: CLAR-15013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Individual participant data will be provided to each respective investigator at the end of the trial.