Back to resultsStudy On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
Primary Purpose
Hypogonadism, Hypogonadism, Male
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nanomilled testosterone
commercially available dutasteride
Nanomilled dutasteride
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism focused on measuring Testosterone, Men, Hypogonadism, Dutasteride, DHT, Androgen deficiency
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
lab tests for relative bioavailability of testosterone and dutasteride,
Secondary Outcome Measures
safety lab tests of various testosterone/dutasteride formulations,
lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00400335
Brief Title
Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Hypogonadism, Male
Keywords
Testosterone, Men, Hypogonadism, Dutasteride, DHT, Androgen deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nanomilled testosterone
Intervention Type
Drug
Intervention Name(s)
commercially available dutasteride
Intervention Type
Drug
Intervention Name(s)
Nanomilled dutasteride
Other Intervention Name(s)
commercially available dutasteride, Nanomilled testosterone
Primary Outcome Measure Information:
Title
lab tests for relative bioavailability of testosterone and dutasteride,
Time Frame
days 1, 2, 3, 19, 20, 21 & 26-31
Secondary Outcome Measure Information:
Title
safety lab tests of various testosterone/dutasteride formulations,
Time Frame
days 1, 2, 3, 19, 20, 21 & 26-31.
Title
lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,
Time Frame
days 1, 2, 3, 19, 20, 21 & 26-31.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98418
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
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