NCT00802035
Completed
Phase 1
A Phase 1, Single-Center, Open-Label Study of the Pharmacokinetics of Baclofen Formulations Administered to Healthy Adults
Overview
- Phase
- Phase 1
- Intervention
- Baclofen IR
- Conditions
- Alcohol Dependence
- Sponsor
- Alkermes, Inc.
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Maximum plasma concentration (Cmax)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.
Investigators
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
Arms & Interventions
IR am
30 mg, single dose, morning administration (immediate release \[IR\])
Intervention: Baclofen IR
ER am
30 mg; single dose; morning administration (extended release \[ER\])
Intervention: Baclofen ER
ER pm
30 mg; single dose; evening administration
Intervention: Baclofen ER
IR pm
30 mg; single dose; evening administration
Intervention: Baclofen IR
Outcomes
Primary Outcomes
Maximum plasma concentration (Cmax)
Time Frame: 5 weeks
Secondary Outcomes
- Significant abnormal laboratory findings(5 weeks)
- Area under the plasma concentration curve (AUC)(5 weeks)
- Time to Cmax(5 weeks)
Study Sites (1)
Loading locations...
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