ALK29-002: A Study of Baclofen Formulations in Healthy Adults
- Registration Number
- NCT00802035
- Lead Sponsor
- Alkermes, Inc.
- Brief Summary
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ER am Baclofen ER 30 mg; single dose; morning administration (extended release \[ER\]) ER pm Baclofen ER 30 mg; single dose; evening administration IR am Baclofen IR 30 mg, single dose, morning administration (immediate release \[IR\]) IR pm Baclofen IR 30 mg; single dose; evening administration
- Primary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) 5 weeks
- Secondary Outcome Measures
Name Time Method Time to Cmax 5 weeks Significant abnormal laboratory findings 5 weeks Area under the plasma concentration curve (AUC) 5 weeks
Trial Locations
- Locations (1)
CEDRA Clinical Research, LLC
🇺🇸Austin, Texas, United States