Phlebotomy Study of Testosterone Undecanoate

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670343
• Other study ID #: CLAR-15013
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 28, 2016
• Last updated: February 23, 2018
• Start date: January 2016
• Est. completion date: March 2016

Study information

• Verified date: February 2018
• Source: Clarus Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Oral Testosterone Undecanoate
Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.

Locations

Country	Name	City	State
United States	Los Angeles Biomedical Research Institute	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Clarus Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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.