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

Alcohol Dependence Clinical Trial

Official title:

A Phase 1, Single-Center, Open-Label Study of the Pharmacokinetics of Baclofen Formulations Administered to Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802035
• Other study ID #: ALK29-002
• Status: Completed
• Phase: Phase 1
• First received: November 26, 2008
• Last updated: August 22, 2011
• Start date: November 2008
• Est. completion date: February 2009

Study information

• Verified date: August 2011
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Baclofen IR
30 mg; single dose
• Baclofen ER
30 mg; single dose

Locations

Country	Name	City	State
United States	CEDRA Clinical Research, LLC	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax)		5 weeks	No
Secondary	Time to Cmax		5 weeks	No
Secondary	Significant abnormal laboratory findings		5 weeks	Yes
Secondary	Area under the plasma concentration curve (AUC)		5 weeks	No