Phlebotomy Study of Testosterone Undecanoate

NCT ID: NCT02670343

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-03-31

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.

Conditions

Hypogonadism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oral Testosterone Undecanoate

Intervention Type: DRUG

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

Interventions

Oral Testosterone Undecanoate

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

Intervention Type: DRUG

Other Intervention Names

testosterone undecanoate

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Clarus Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Locations

Los Angeles Biomedical Research Institute

Torrance, California, United States

Countries

United States

Other Identifiers

CLAR-15013

Identifier Type: -

Identifier Source: org_study_id