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

Alkermes

Status and phase: Completed; Phase 1

Conditions: Alcohol Dependence

Treatments: Drug: Baclofen IR; Drug: Baclofen ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT00802035

ALK29-002

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

IR am

Active Comparator group

Description:

30 mg, single dose, morning administration (immediate release \[IR\])

Treatment:

Drug: Baclofen IR

ER am

Experimental group

Description:

30 mg; single dose; morning administration (extended release \[ER\])

Treatment:

Drug: Baclofen ER

ER pm

Experimental group

Description:

30 mg; single dose; evening administration

Treatment:

Drug: Baclofen ER

IR pm

Active Comparator group

Description:

30 mg; single dose; evening administration

Treatment:

Drug: Baclofen IR