ALK29-002: A Study of Baclofen Formulations in Healthy Adults

Completed · Phase 1

Conditions studied: Alcohol Dependence

In brief

The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.

Key facts

Study ID

NCT00802035

Run by

Alkermes, Inc.

People needed

16

Starts

2008-11-01

Expected to finish

2009-02-01

Last updated by the study team

2011-08-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CEDRA Clinical Research, LLC — Austin, Texas, United States

Full record on ClinicalTrials.gov

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