Alcohol DependencePhase 1NCT00802035
ALK29-002: A Study of Baclofen Formulations in Healthy Adults
A Phase 1 study testing Baclofen IR and Baclofen ER in people with Alcohol Dependence, run by Alkermes, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Baclofen IR and Baclofen ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Center, Open-Label Study of the Pharmacokinetics of Baclofen Formulations Administered to Healthy Adults
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.
- Conditions
- Alcohol Dependence
- Being tested
- Baclofen IR, Baclofen ER
- Keywords
- ALK29, Alcohol Dependence, Pharmacokinetics
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baclofen IRDrug
30 mg; single dose
Baclofen ERDrug
30 mg; single dose
| Study group | Role | What they receive |
|---|---|---|
| IR am | Active comparator | 30 mg, single dose, morning administration (immediate release [IR]) Receives: Drug: Baclofen IR |
| ER am | Experimental | 30 mg; single dose; morning administration (extended release [ER]) Receives: Drug: Baclofen ER |
| ER pm | Experimental | 30 mg; single dose; evening administration Receives: Drug: Baclofen ER |
| IR pm | Active comparator | 30 mg; single dose; evening administration Receives: Drug: Baclofen IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Measured: 5 weeks
Secondary outcomes (3)
Time to Cmax
Measured: 5 weeks
Significant abnormal laboratory findings
Measured: 5 weeks
Area under the plasma concentration curve (AUC)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederick A. Bieberdorf, MD, CPI, Principal investigator, CEDRA Clinical Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802035
- Sponsor's protocol ID
- ALK29-002
- Status last verified
- Aug 2011
- First submitted
- 26 Nov 2008
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Open-Label Study of the Pharmacokinetics of Baclofen Formulations Administered to Healthy Adults
- ClinicalTrials.gov ID
- NCT00802035
- Acronym / sponsor ID
- ALK29-002
- Conditions
- Alcohol Dependence
- Keywords
- ALK29, Alcohol Dependence, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 4 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IR am | Active comparator | Drug: Baclofen IR30 mg, single dose, morning administration (immediate release [IR]) |
| ER am | Experimental | Drug: Baclofen ER30 mg; single dose; morning administration (extended release [ER]) |
| ER pm | Experimental | Drug: Baclofen ER30 mg; single dose; evening administration |
| IR pm | Active comparator | Drug: Baclofen IR30 mg; single dose; evening administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baclofen IR30 mg; single dose | Drug | IR am, IR pm |
| Baclofen ER30 mg; single dose | Drug | ER am, ER pm |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: 5 weeks
3 secondary outcomes
Time to Cmax
Time frame: 5 weeks
Significant abnormal laboratory findings
Time frame: 5 weeks
Area under the plasma concentration curve (AUC)
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick A. Bieberdorf, MD, CPI principal investigator
CEDRA Clinical Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Baclofen IR and Baclofen ER in people with Alcohol Dependence, run by Alkermes, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2011.