Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism
Intervention: Nanomilled testosterone (Drug); commercially available dutasteride (Drug); Nanomilled dutasteride (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, M.D., Ph.D., FACP, Study Director, Affiliation: GlaxoSmithKline
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
Clinical Details
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 design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: lab tests for relative bioavailability of testosterone and dutasteride,
Secondary outcome: safety lab tests of various testosterone/dutasteride formulations,lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Tacoma, Washington 98418, United States
Additional Information
Starting date: October 2006
Last updated: September 4, 2007
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