Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects
Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
UConn Health
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institutes of Health (NIH)