Alcohol Dependence
Conditions
Keywords
ALK29, Alcohol Dependence, Pharmacokinetics
Brief summary
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.
Interventions
DRUGBaclofen IR
30 mg; single dose
DRUGBaclofen ER
30 mg; single dose
Sponsors
Alkermes, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration (Cmax) | 5 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to Cmax | 5 weeks |
| Significant abnormal laboratory findings | 5 weeks |
| Area under the plasma concentration curve (AUC) | 5 weeks |
Countries
United States
Outcome results
None listed