- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01346319
Study of the Safety, Tolerability and Pharmacokinetics of Testosterone Undecanoate in Hypogonadal Males.
November 1, 2011 updated by: Abbott
A Randomized Double-Blind, Placebo-controlled Dose Escalating Study of the Pharmacokinetics, Safety and Tolerability of Testosterone Undecanoate (ABT-SLV361) in Hypogonadal Males
Phase 1 Dose Escalating Study of the safety, tolerability and pharmacokinetics of testosterone in hypogonadal males.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Fort Myers, Florida, United States, 33901-0000
- Site Reference ID/Investigator# 51964
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
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.
|
Active Comparator: Testosterone undecanoate
|
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.
|
What is the study measuring?
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
Time Frame: During confinement
|
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
Time Frame: During confinement
|
Blood sample results for testosterone undecanoate
|
During confinement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bela Denes, MD, Abbott
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
April 20, 2011
First Submitted That Met QC Criteria
May 2, 2011
First Posted (Estimate)
May 3, 2011
Study Record Updates
Last Update Posted (Estimate)
November 3, 2011
Last Update Submitted That Met QC Criteria
November 1, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- M12-778
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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