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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes
ClinicalTrials.gov Identifier:
NCT00802035
First received: November 26, 2008
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

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:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802035

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

No publications provided

Responsible Party: Alkermes
ClinicalTrials.gov 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:
ALK29
Alcohol Dependence
Pharmacokinetics

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Baclofen
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014