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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00400335
Other study ID # TDC106222
Secondary ID
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
Est. completion date
Est. primary completion date
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


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.
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