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

This study has been completed.
Information provided by (Responsible Party):
Alkermes, Inc. Identifier:
First received: November 26, 2008
Last updated: August 22, 2011
Last verified: August 2011
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.

Condition Intervention Phase
Alcohol Dependence
Drug: Baclofen IR
Drug: Baclofen ER
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Single-Center, Open-Label Study of the Pharmacokinetics of Baclofen Formulations Administered to Healthy Adults

Resource links provided by NLM:

Further study details as provided by Alkermes, Inc.:

Primary Outcome Measures:
  • Maximum plasma concentration (Cmax) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Cmax [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Significant abnormal laboratory findings [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
  • Area under the plasma concentration curve (AUC) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: November 2008
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IR am
30 mg, single dose, morning administration (immediate release [IR])
Drug: Baclofen IR
30 mg; single dose
Experimental: ER am
30 mg; single dose; morning administration (extended release [ER])
Drug: Baclofen ER
30 mg; single dose
Experimental: ER pm
30 mg; single dose; evening administration
Drug: Baclofen ER
30 mg; single dose
Active Comparator: IR pm
30 mg; single dose; evening administration
Drug: Baclofen IR
30 mg; single dose


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00802035

United States, Texas
CEDRA Clinical Research, LLC
Austin, Texas, United States, 78759
Sponsors and Collaborators
Alkermes, Inc.
Principal Investigator: Frederick A. Bieberdorf, MD, CPI CEDRA Clinical Research, LLC
  More Information

Responsible Party: Alkermes, Inc. Identifier: NCT00802035     History of Changes
Other Study ID Numbers: ALK29-002 
Study First Received: November 26, 2008
Last Updated: August 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Alkermes, Inc.:
Alcohol Dependence

Additional relevant MeSH terms:
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders processed this record on April 27, 2016