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

Phase 1

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: Baclofen ER; Drug: Baclofen IR

• Registration Number: NCT00802035
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-26
• Primary Completion: 2008-12
• Study First Submitted QC: 2008-12-03
• Study First Posted: 2008-12-04
• Study Completion: 2009-02
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-22
• Last Update Posted: 2011-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ER am	Baclofen ER	30 mg; single dose; morning administration (extended release \[ER\])
ER pm	Baclofen ER	30 mg; single dose; evening administration
IR am	Baclofen IR	30 mg, single dose, morning administration (immediate release \[IR\])
IR pm	Baclofen IR	30 mg; single dose; evening administration

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax)	5 weeks

Secondary Outcome Measures

Name	Time	Method
Time to Cmax	5 weeks
Significant abnormal laboratory findings	5 weeks
Area under the plasma concentration curve (AUC)	5 weeks

Trial Locations

Locations (1)

CEDRA Clinical Research, LLC; 🇺🇸 Austin, Texas, United States