Status:
COMPLETED
ALK29-002: A Study of Baclofen Formulations in Healthy Adults
Lead Sponsor:
Alkermes, Inc.
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.
Eligibility Criteria
Inclusion
- Between the ages of 18 and 65 years
- Body mass index of 19 to 30 kg/m2 at screening
- If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception for the duration of the study
Exclusion
- Pregnancy and/or currently breastfeeding
- Clinical significant medical condition or observed abnormalities
- Acute gastrointestinal disorder or history of chronic gastrointestinal disease or surgery
- Participation in a clinical trial within 30 days before screening
- Known intolerance and/or hypersensitivity to baclofen or its excipients
- Use of alcohol-, caffeine-, or xanthine-containing products
- Clinically significant illness within 30 days of first study drug administration
- Dietary restrictions that conflict with required study meals
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00802035
Start Date
November 1 2008
End Date
February 1 2009
Last Update
August 23 2011
Active Locations (1)
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1
CEDRA Clinical Research, LLC
Austin, Texas, United States, 78759