Phlebotomy Study of Testosterone Undecanoate

NCT02670343 | Completed Phase 1 Results

• 1 other identifier: CLAR-15013
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (1)

• % 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.

Study Arms (1)

Oral Testosterone Undecanoate

EXPERIMENTAL

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

Interventions

Oral Testosterone Undecanoate DRUG

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

Also known as: testosterone undecanoate

Oral Testosterone Undecanoate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Clarus Therapeutics, Inc.: lead

Study Sites (1)

Los Angeles Biomedical Research Institute

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Christina Wang, MDAssociate Director UCLA Clinical and Translational Science Institute
• Organization: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

wang@labiomed.org

1-310-222-1888

Study Officials

• Christina Wang, M.D.

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 1, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 9, 2018
• Results First Posted: March 9, 2018

Record last verified: 2018-02

Locations

US (1)