Back to resultsALK29-002: A Study of Baclofen Formulations in Healthy Adults
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Baclofen IR
Baclofen ER
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring ALK29, Alcohol Dependence, Pharmacokinetics
Eligibility 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
Sites / Locations
- CEDRA Clinical Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Active Comparator
Arm Label
IR am
ER am
ER pm
IR pm
Arm Description
30 mg, single dose, morning administration (immediate release [IR])
30 mg; single dose; morning administration (extended release [ER])
30 mg; single dose; evening administration
30 mg; single dose; evening administration
Outcomes
Primary Outcome Measures
Maximum plasma concentration (Cmax)
Secondary Outcome Measures
Time to Cmax
Significant abnormal laboratory findings
Area under the plasma concentration curve (AUC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00802035
Brief Title
ALK29-002: A Study of Baclofen Formulations in Healthy Adults
Official Title
A Phase 1, Single-Center, Open-Label Study of the Pharmacokinetics of Baclofen Formulations Administered to Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
ALK29, Alcohol Dependence, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IR am
Arm Type
Active Comparator
Arm Description
30 mg, single dose, morning administration (immediate release [IR])
Arm Title
ER am
Arm Type
Experimental
Arm Description
30 mg; single dose; morning administration (extended release [ER])
Arm Title
ER pm
Arm Type
Experimental
Arm Description
30 mg; single dose; evening administration
Arm Title
IR pm
Arm Type
Active Comparator
Arm Description
30 mg; single dose; evening administration
Intervention Type
Drug
Intervention Name(s)
Baclofen IR
Intervention Description
30 mg; single dose
Intervention Type
Drug
Intervention Name(s)
Baclofen ER
Intervention Description
30 mg; single dose
Primary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax)
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Time to Cmax
Time Frame
5 weeks
Title
Significant abnormal laboratory findings
Time Frame
5 weeks
Title
Area under the plasma concentration curve (AUC)
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick A. Bieberdorf, MD, CPI
Organizational Affiliation
CEDRA Clinical Research, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEDRA Clinical Research, LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ALK29-002: A Study of Baclofen Formulations in Healthy Adults
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