ALK29-002: A Study of Baclofen Formulations in Healthy Adults
A Phase 1, Single-Center, Open-Label Study of the Pharmacokinetics of Baclofen Formulations Administered to Healthy Adults
1 other identifier
interventional
16
1 country
1
Brief Summary
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedFirst Posted
Study publicly available on registry
December 4, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedAugust 23, 2011
August 1, 2011
1 month
November 26, 2008
August 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum plasma concentration (Cmax)
5 weeks
Secondary Outcomes (3)
Time to Cmax
5 weeks
Significant abnormal laboratory findings
5 weeks
Area under the plasma concentration curve (AUC)
5 weeks
Study Arms (4)
IR am
ACTIVE COMPARATOR30 mg, single dose, morning administration (immediate release \[IR\])
ER am
EXPERIMENTAL30 mg; single dose; morning administration (extended release \[ER\])
ER pm
EXPERIMENTAL30 mg; single dose; evening administration
IR pm
ACTIVE COMPARATOR30 mg; single dose; evening administration
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (1)
CEDRA Clinical Research, LLC
Austin, Texas, 78759, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederick A. Bieberdorf, MD, CPI
CEDRA Clinical Research, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2008
First Posted
December 4, 2008
Study Start
November 1, 2008
Primary Completion
December 1, 2008
Study Completion
February 1, 2009
Last Updated
August 23, 2011
Record last verified: 2011-08