Phlebotomy Study of Testosterone Undecanoate

Completed · Phase 1/Phase 2

Conditions studied: Hypogonadism

In brief

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.

Key facts

Study ID

NCT02670343

Run by

Clarus Therapeutics, Inc.

People needed

8

Starts

2016-01-01

Expected to finish

2016-03-01

Last updated by the study team

2018-03-09

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

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…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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