ALK29-002: A Study of Baclofen Formulations in Healthy Ad... | NCT00802035

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

NCT00802035

Sponsor

Alkermes, Inc.

Status

Completed

Last Update Posted

Aug 23, 2011Estimated

Enrollment

16Actual

Phase

Phase 1

Conditions

Alcohol Dependence

Interventions

Baclofen IR
Baclofen ER

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Feb 2009Actual

First Submitted Date

Nov 26, 2008

First Submission Date that Met QC Criteria

Dec 3, 2008

First Posted Date

Dec 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2011

Last Update Posted Date

Aug 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IR am	Active Comparator	30 mg, single dose, morning administration (immediate release [IR])	Drug: Baclofen IR
ER am	Experimental	30 mg; single dose; morning administration (extended release [ER])	Drug: Baclofen ER
ER pm	Experimental	30 mg; single dose; evening administration	Drug: Baclofen ER
IR pm	Active Comparator	30 mg; single dose; evening administration	Drug: Baclofen IR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Baclofen IR	Drug	30 mg; single dose	IR am IR pm
Baclofen ER

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum plasma concentration (Cmax)		5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Time to Cmax		5 weeks
Significant abnormal laboratory findings		5 weeks
Area under the plasma concentration curve (AUC)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederick A. Bieberdorf, MD, CPI	CEDRA Clinical Research, LLC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CEDRA Clinical Research, LLC		Austin	Texas	78759	United States

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided