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

• Status: Terminated
• Trial end date: 2018-05-03
• Target enrollment: 0
• Participant gender: Male

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 optimum dosing conditions;

3. evaluate the efficacy of single or multiple daily adaptive dosing; and

4. evaluate the safety and tolerability of TSX-011.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TesoRx Pharma, LLC
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Testosterone level <350 ng/dL, 10 am [± 2 hour] sample.

• Body mass index (BMI) <35.0 kg/m2 and weight ≥50 kg

Exclusion Criteria:

• 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:

1. 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).

2. Known or suspected carcinoma (or history of carcinoma) of the breast.

3. Liver disease defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × upper limit of normal (ULN) or bilirubin >2 × ULN.

4. Active deep vein thrombosis or thromboembolic disorder, or a documented history of these conditions.

5. Untreated sleep apnea.

6. Hematocrit >50%.

7. 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.