Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT00802321|
Recruitment Status : Completed
First Posted : December 4, 2008
Last Update Posted : September 23, 2010
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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|
Subjects will receive a single dose of 2, 3 or 4 mg of dutasteride based on random assignment.
Other Name: Avodart
- 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 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00802321
|United States, Connecticut|
|Unversity of Connecticut Health Center|
|Farmington, Connecticut, United States, 06030|
|Principal Investigator:||Jonathan Covault, M.D, Ph.D||UConn Health|