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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Hypogonadism

Hypogonadism, Male

Treatments

Drug: Nanomilled dutasteride

Drug: commercially available dutasteride

Drug: Nanomilled testosterone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00400335

TDC106222

Details and patient eligibility

About

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

Enrollment

60 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.