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Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00400335
First received: November 14, 2006
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone administered with and without dutasteride


Condition Intervention Phase
Hypogonadism
Hypogonadism, Male
Drug: Nanomilled testosterone
Drug: commercially available dutasteride
Drug: Nanomilled dutasteride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Evaluate the Impact of Novel Fixed-dose Testosterone/Dutasteride Combinations on the Relative Bioavailability of the Individual Dutasteride and Testosterone Components

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • lab tests for relative bioavailability of testosterone and dutasteride, [ Time Frame: days 1, 2, 3, 19, 20, 21 & 26-31 ]

Secondary Outcome Measures:
  • safety lab tests of various testosterone/dutasteride formulations, [ Time Frame: days 1, 2, 3, 19, 20, 21 & 26-31. ]
  • lab tests for additional pharmacokinetic parameters for testosterone & dutasteride, [ Time Frame: days 1, 2, 3, 19, 20, 21 & 26-31. ]

Enrollment: 60
Study Start Date: October 2006
Intervention Details:
    Drug: Nanomilled testosterone Drug: commercially available dutasteride Drug: Nanomilled dutasteride
    Other Names:
    • Nanomilled dutasteride
    • commercially available dutasteride
    • Nanomilled testosterone
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Are healthy.
  • Have a BMI within range of 19-32 kg/m2.
  • Have not taken dutasteride for one year, or finasteride for the past 3 months.
  • Have a screening PSA < 2.0ng/mL.

Exclusion criteria:

  • Have had or have breast or prostate cancer, sleep apnea, psychiatric illness, or any other clinically significant current condition.
  • Have a trigliceride level =500mg/dL.
  • Have abnormal thyroid or hormone levels.
  • Would donate more than 500 ML of blood over a 2 month period.
  • Physician does not think it is a good idea for you to participate in the trial.
  • Are unwilling to abstain from alcohol during the study.
  • Have a positive urine drug screen test.
  • Plan to change your smoking habits during the course of the trial.
  • Have Hepatitis C, Hepatitis B, or HIV.
  • Have a lab or ECG abnormality.
  • Have high or low blood pressure.
  • Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400335

Locations
United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00400335     History of Changes
Other Study ID Numbers: TDC106222
Study First Received: November 14, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Testosterone
Men
Hypogonadism
Dutasteride
DHT
Androgen deficiency

Additional relevant MeSH terms:
Hypogonadism
Endocrine System Diseases
Gonadal Disorders
Dutasteride
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
5-alpha Reductase Inhibitors
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 25, 2014