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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01346319
First received: April 20, 2011
Last updated: November 1, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Hypogonadal Males
 Drug: ABT-SLV361
Drug: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind, Placebo-controlled Dose Escalating Study of the Pharmacokinetics, Safety and Tolerability of Testosterone Undecanoate (ABT-SLV361) in Hypogonadal Males

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • To determine the pharmacokinetics of testosterone after multiple oral doses of ABT-SLV361 in hypogonadal males [ Time Frame: During confinement ] [ Designated as safety issue: No ]
    Blood sample results for testosterone


Secondary Outcome Measures:
  • To determine the pharmacokinetic of testosterone undecanoate after multiple oral doses of ABT-SLV361 in hypogonadal males [ Time Frame: During confinement ] [ Designated as safety issue: No ]
    Blood sample results for testosterone undecanoate


Enrollment: 0
Study Start Date: April 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Testosterone undecanoate Drug: ABT-SLV361
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.
Other Name: ABT-SLV361
Placebo Comparator: Placebo Drug: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. 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.
  2. 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.
  3. 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.
  4. 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

  1. History of significant sensitivity or allergy to any drug, including androgens, castor oil or product excipients.
  2. Previous history or current or suspected prostate or breast cancer, and/or previous history of cancer (except basal cell carcinoma of the skin).
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346319

Locations
United States, Florida
Site Reference ID/Investigator# 51964
Fort Myers, Florida, United States, 33901-0000
Sponsors and Collaborators
Abbott
Investigators
Study Director: Bela Denes, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01346319     History of Changes
Other Study ID Numbers: M12-778
Study First Received: April 20, 2011
Last Updated: November 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
dose escalating

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 19, 2013