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

May 31, 2012 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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

  • United States
    • Washington
      • Tacoma, Washington, United States, 98418
        • GSK Investigational Site

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 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

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
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
safety lab tests of various testosterone/dutasteride formulations,
Time Frame: days 1, 2, 3, 19, 20, 21 & 26-31.
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.
days 1, 2, 3, 19, 20, 21 & 26-31.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

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

October 1, 2006

Study Registration Dates

First Submitted

November 14, 2006

First Submitted That Met QC Criteria

November 14, 2006

First Posted (ESTIMATE)

November 16, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDC106222

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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