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

This study has been completed.

First Received: November 14, 2006 Last Updated: October 9, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00400335

Purpose

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

Condition	Intervention	Phase
Hypogonadism	Drug: Nanomilled testosterone Drug: commercially available dutasteride Drug: Nanomilled dutasteride	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics/Dynamics Study
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

Resource links provided by NLM:

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Dutasteride Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome 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. ]

Enrollment:	60
Study Start Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400335

Locations

United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98418

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, M.D., Ph.D., FACP

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TDC106222
Study First Received:	November 14, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00400335 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Hypogonadism
Testosterone
Dutasteride

DHT
Androgen deficiency
Men

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Testosterone 17 beta-cypionate
Dutasteride
Anabolic Agents
Testosterone
Hypogonadism
Endocrinopathy
Androgens

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Enzyme Inhibitors
Methyltestosterone

Hormones
Pharmacologic Actions
Testosterone 17 beta-cypionate
Dutasteride
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on September 03, 2009