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

Hypogonadism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400335
• Other study ID #: TDC106222
• Status: Completed
• Phase: Phase 1
• First received: November 14, 2006
• Last updated: May 31, 2012
• Start date: October 2006

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadism, Male

Intervention

Drug:
• Nanomilled testosterone

• commercially available dutasteride

• Nanomilled dutasteride

Locations

Country	Name	City	State
United States	GSK Investigational Site	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lab tests for relative bioavailability of testosterone and dutasteride,		days 1, 2, 3, 19, 20, 21 & 26-31
Secondary	safety lab tests of various testosterone/dutasteride formulations,		days 1, 2, 3, 19, 20, 21 & 26-31.
Secondary	lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,		days 1, 2, 3, 19, 20, 21 & 26-31.