A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males

Stopped early · Phase 1/Phase 2

Conditions studied: Hypogonadism, Hypogonadism, Male, Gonadal Disorders, Endocrine System Diseases, Testosterone Deficiency

In brief

This will be a phase 1/2a, open-label, single-center study with 3 periods. The aims of the study are to: 1. evaluate the dose-response curve following ascending single doses of TSX-011; 2. confirm optimum dosing conditions; 3. evaluate the efficacy of single or multiple daily adaptive dosing; and 4. evaluate the safety and tolerability of TSX-011.

Key facts

Study ID

NCT03335254

Run by

TesoRx Pharma, LLC

People needed

9

Starts

2017-11-06

Expected to finish

2018-05-03

Last updated by the study team

2019-05-16

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Testosterone level <350 ng/dL, 10 am [± 2 hour] sample.
• Body mass index (BMI) <35.0 kg/m2 and weight ≥50 kg

You may not qualify if…

• History of clinically significant renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition.
• Significant gastrointestinal or malabsorption conditions.
• Any man in whom testosterone therapy is contraindicated including the following:
• Known or suspected carcinoma (or history of carcinoma) of the prostate, clinically significant symptoms of benign prostatic hyperplasia, and/or clinically significant symptoms of lower urinary obstruction and International Prostate Symptom Score (IPSS) ≥19. A clinically significant digital rectal examination of the prostate or clinically significant elevated serum PSA levels (>4.0 ng/mL).
• Known or suspected carcinoma (or history of carcinoma) of the breast.
• Liver disease defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × upper limit of normal (ULN) or bilirubin >2 × ULN.
• Active deep vein thrombosis or thromboembolic disorder, or a documented history of these conditions.
• Untreated sleep apnea.
• Hematocrit >50%.
• Untreated moderate to severe depression.
• Current use of long-acting testosterone or any of the testosterone esters injectables.
• Topical, oral, or injectable testosterone replacement therapy.
• Clinically significant changes in any medications (including dosages) or medical conditions in the 28 days before screening.
• Suspected reversible hypogonadism (e.g., leuprolide injection).
• Taking concomitant medications that affect testosterone concentrations or metabolism
• Uncontrolled diabetes (screening glycated hemoglobin [HbA1c] ≥9%).
• Donated blood or blood products or experienced significant blood loss within 90 days before dosing.
• Donated bone marrow within 6 months before dosing.
• History of drug or alcohol abuse in the last 6 months.
• Ingested St John's wort within 30 days of screening.

Where it is running

• California Clinical Trials — Glendale, California, United States

Full record on ClinicalTrials.gov

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