Last updated: 11/04/2018 12:48:10
Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
GSK study ID
TDC106222
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
lab tests for relative bioavailability of testosterone and dutasteride,
Timeframe: days 1, 2, 3, 19, 20, 21 & 26-31
Secondary outcomes:
safety lab tests of various testosterone/dutasteride formulations,
Timeframe: days 1, 2, 3, 19, 20, 21 & 26-31.
lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,
Timeframe: days 1, 2, 3, 19, 20, 21 & 26-31.
Interventions:
Drug: Nanomilled testosterone
Drug: commercially available dutasteride
Drug: Nanomilled dutasteride
Enrollment:
60
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hypogonadism
Product
dutasteride, testosterone
Collaborators
Not applicable
Study date(s)
October 2006 to April 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
- Are healthy.
- Have a BMI within range of 19-32 kg/m2.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Tacoma, Washington, United States, 98418
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-11-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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