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

A Phase 1, Single-Center, Open-Label Study of the Pharmacokinetics of Baclofen Formulations Administered to Healthy Adults

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

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