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”

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 Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

• Drug: Nanomilled testosterone
• Drug: commercially available dutasteride
• Drug: Nanomilled dutasteride

Primary Measures

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

Secondary 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.
    

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, M.D., Ph.D., FACP Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on September 01, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00400335

Study ID Number: TDC106222

ClinicalTrials.gov Identifier: NCT00400335

Health Authority: United States: Food and Drug Administration