Alcoholism Clinical Trial
Official title:
Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects
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.
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. ;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver)
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