Status:
TERMINATED
A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males
Lead Sponsor:
TesoRx Pharma, LLC
Conditions:
Hypogonadism
Hypogonadism, Male
Eligibility:
MALE
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 op...
Detailed Description
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 opt...
Eligibility Criteria
Inclusion
- Testosterone level \<350 ng/dL, 10 am \[± 2 hour\] sample.
- Body mass index (BMI) \<35.0 kg/m2 and weight ≥50 kg
Exclusion
- 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.
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03335254
Start Date
November 6 2017
End Date
May 3 2018
Last Update
May 16 2019
Active Locations (1)
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1
California Clinical Trials
Glendale, California, United States, 91206