Study of the Safety, Tolerability and Pharmacokinetics of Testosterone Undecanoate in Hypogonadal Males.

Study Overview
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Brief Summary
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Phase 1 Dose Escalating Study of the safety, tolerability and pharmacokinetics of testosterone in hypogonadal males.

Detailed Description
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M12-778 is a rising multiple dose, randomized, double blind, placebo controlled single center study. It will have 5 dose groups of 20 subjects in dose groups 1,2 and 3 and 24 subjects in dose groups 4 and 5; a total of 84 subjects . There will be a 7 day period between dose groups 1,2 and 3 to assess the safety of increasing to the next dose. Dose groups of 4 and 5 will be run in parallel. Subjects will be confined in center for 20 days for dose groups 1,2 and 3 and 33 days for dose groups 4 and 5.

Official Title
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A Randomized Double-Blind, Placebo-controlled Dose Escalating Study of the Pharmacokinetics, Safety and Tolerability of Testosterone Undecanoate (ABT-SLV361) in Hypogonadal Males

Conditions
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Hypogonadal Males

Intervention / Treatment
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* Drug: ABT-SLV361
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Serum total testosterone < 300 ng/dL based on two blood samples obtained between 6 and 10 AM on two separate occasions at least 48 hours apart. Previously documented total testosterone results obtained within 6 weeks of Study Day -2 may be used during screening for subjects not currently on androgen replacement therapy, or following washout of androgen replacement therapy. Subjects naïve to androgen replacement or washout of 12 weeks following intramuscular androgen injections; 4 weeks following topical or buccal androgens; and 3 weeks following oral androgens. Washout should be completed by Study Day -2. Subject is judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12 lead electrocardiogram (ECG) performed at Screening. Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Exclusion Criteria History of significant sensitivity or allergy to any drug, including androgens, castor oil or product excipients. Previous history or current or suspected prostate or breast cancer, and/or previous history of cancer (except basal cell carcinoma of the skin). Subjects not on a stable medication regimen for at least three months for the treatment of a chronic condition such as hypertension, hyperlipidemia or diabetes mellitus. Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior to study drug administration and through the end of the study. Use of any drug within 5 half-lives of the last dose in the past 6 months prior to Study Day -2 without principal investigator and/or sponsor approval. Receipt of any drug by injection within 30 days or 10 half-lives (which ever is longer) prior to study drug administration without principal investigator and/or sponsor approval.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Testosterone undecanoate<br> | Drug: ABT-SLV361<br>* For dose groups 1, 2 and 3 medication is taken 1 time per day the first day followed by 2 times per day for 14 days. For dose groups 4 and 5, medication is taken 1 time per day for the first day followed by 2 times per day for 28 days.<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* For dose groups 1, 2 and 3 medication is taken 1 time per day the first day followed by 2 times per day for 14 days. For dose groups 4 and 5, medication is taken 1 time per day for the first day followed by 2 times per day for 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetics of testosterone after multiple oral doses of ABT-SLV361 in hypogonadal males | Blood sample results for testosterone | During confinement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetic of testosterone undecanoate after multiple oral doses of ABT-SLV361 in hypogonadal males | Blood sample results for testosterone undecanoate | During confinement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dose escalating