Status:
COMPLETED
Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects
Lead Sponsor:
UConn Health
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Related Disorders
Alcoholism
Eligibility:
MALE
21-55 years
Phase:
NA
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 b...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00802321
Start Date
April 1 2006
End Date
November 1 2006
Last Update
September 23 2010
Active Locations (1)
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1
Unversity of Connecticut Health Center
Farmington, Connecticut, United States, 06030