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Completed

NCT Number: NCT00802035

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

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

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CEDRA Clinical Research, LLC

Austin, Texas, 78759, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baclofen IR

Drug

30 mg; single dose

Baclofen ER

Drug

30 mg; single dose

Primary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: 5 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Dec 4, 2008
Registry last updated
Aug 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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