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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00802035
Recruitment Status : Completed
First Posted : December 4, 2008
Last Update Posted : August 23, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Baclofen IR Drug: Baclofen ER Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : November 2008
Primary Completion Date : December 2008
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. Time to Cmax [ Time Frame: 5 weeks ]
  2. Significant abnormal laboratory findings [ Time Frame: 5 weeks ]
  3. Area under the plasma concentration curve (AUC) [ Time Frame: 5 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802035


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

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT00802035     History of Changes
Other Study ID Numbers: ALK29-002
First Posted: December 4, 2008    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: August 2011

Keywords provided by Alkermes, Inc.:
ALK29
Alcohol Dependence
Pharmacokinetics

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders