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Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00802321
Recruitment Status : Completed
First Posted : December 4, 2008
Last Update Posted : September 23, 2010
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
UConn Health

Brief Summary:

To monitor the inhibition of 5a-reductase (5AR) enzyme activity at 1, 3, 7, 14, 21, 28 and 42 days following administration of a single dose of dutasteride (2, 3, or 4 mg) by measuring the change in blood levels of 3a-androstanediol glucuronide (3a-diolG) and the ratio of dihydrotestosterone (DHT) to testosterone. To accomplish this aim, an open-label, between-subjects dose comparison study design will be employed with subjects receiving a 2, 3, or 4 mg dosage. Subjects (up to n=40 enrolled to allow a minimum of 24 completers) will be randomly assigned to one of the 3 dose levels. Results of this study will inform the dose selection for a subsequent placebo-controlled, within-subject, crossover study of dutasteride on the effects of alcohol.

A secondary aim of this study is to examine the correlation of a genetic variation in the type I 5AR gene and baseline DHT/T ratio and effect of dutasteride at day 3. A variation in this gene which is one of the targets of dutasteride has been reported to be associated with higher baseline levels of DHT.

Condition or disease Intervention/treatment Phase
Alcohol Related Disorders Alcoholism Alcohol Abuse Drug: Dutasteride Not Applicable

Detailed Description:
Alcohol abuse and dependence remain important public health problems. The chemical mechanisms by which alcohol affects the nervous system are not well understood. Recent theories suggest that alcohol stimulates release of "neuroactive" steroid hormones which are important mediators of alcohol effects. This proposal seeks to identify the most appropriate dosage of an FDA approved medication, dutasteride, which blocks the metabolism of steroid hormones, so that we can use dutasteride as a pharmacologic probe of the biochemistry of alcohol effects in human subjects in a subsequent study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Official Title: Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects
Study Start Date : April 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Dutasteride

Arm Intervention/treatment
Experimental: dutasteride Drug: Dutasteride
Subjects will receive a single dose of 2, 3 or 4 mg of dutasteride based on random assignment.
Other Name: Avodart

Primary Outcome Measures :
  1. Change in 5AR enzyme activity as measured by the DHT/testosterone ratio and levels of 3a-androstanediol glucuronide as a function of time after a single loading dose of dutasteride. [ Time Frame: 1-42 days ]

Secondary Outcome Measures :
  1. Secondary outcomes include the moderating effect of genetic variation in type I 5AR enzyme on DHT levels and any effects of dutasteride on subjects self report of alcohol use in their everyday life. [ Time Frame: 1-42 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects will be healthy males volunteers who are 21-55 years old and have a BMI >18.5 and <32.5. All enrolled subjects will have signed IRB approved consent.

Exclusion Criteria:

  • Subjects cannot have a current or past DSM-IV diagnosis of alcohol or drug dependence, current or past 12-months diagnosis of alcohol or drug abuse or major psychiatric disorder, neurological illness, have had a hypersensitivity reaction to dutasteride, physical exam evidence of liver dysfunction, currently be using psychotropic medications or medications that are known to influence steroid hormone levels or metabolism. Nicotine-dependent subjects will be excluded to avoid the confounding effects of nicotine withdrawal during day-long laboratory sessions which are part of the planned alcohol administration study as well as effects of tobacco use on metabolism. Subjects who do not agree to use barrier contraception for 1 week after administration of dutasteride will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00802321

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United States, Connecticut
Unversity of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Principal Investigator: Jonathan Covault, M.D, Ph.D UConn Health
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Responsible Party: Jonathan Covault, M.D., Ph.D., University of Connecticut Health Center Identifier: NCT00802321    
Other Study ID Numbers: 06-217S-2
620 ( Other Grant/Funding Number: GCRC )
5R01AA015606-02 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2008    Key Record Dates
Last Update Posted: September 23, 2010
Last Verified: September 2010
Keywords provided by UConn Health:
steroid 5AReductase
genetic polymorphism
GABA receptor
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs