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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Baclofen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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