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

August 22, 2011 updated by: Alkermes, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78759
        • CEDRA Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum plasma concentration (Cmax)
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Cmax
Time Frame: 5 weeks
5 weeks
Significant abnormal laboratory findings
Time Frame: 5 weeks
5 weeks
Area under the plasma concentration curve (AUC)
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Investigators

  • Principal Investigator: Frederick A. Bieberdorf, MD, CPI, CEDRA Clinical Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

November 26, 2008

First Submitted That Met QC Criteria

December 3, 2008

First Posted (Estimate)

December 4, 2008

Study Record Updates

Last Update Posted (Estimate)

August 23, 2011

Last Update Submitted That Met QC Criteria

August 22, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK29-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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