AlcoholismPhase 1NCT01181908
Alcohol Interaction Study
A Phase 1 study testing single dose in people with Alcoholism, run by GlaxoSmithKline at 1 site in Netherlands.
Trial summary
The purpose of this study is understand the effects of GSK114814 and alcohol in healthy volunteers when taken together. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- What is being tested?
- single dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Nov 2009to 30 Dec 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
- Healthy male and female
- Body weight 50 kg or higher and BMI within the range 19 - 29.9 kg/m2
- Willing to use appropriate contraception methods
Who cannot join
- Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody result
- Any serious medical disorder or condition
- Any history of an endocrine disorder.
- Any clinically significant laboratory abnormality.
- History of psychiatric illness.
- Any history of suicidal attempts or behavior.
Show all 11Show fewer
- Positive urine drug screen or positive blood alcohol
- Pregnant, nursing or potential to have a child
- Past history of alcohol dependence or abuse.
- History of increased sensitivity to the effects of alcohol or violent behaviour/aggression when intoxicated.
- smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Investigate the Psychomotor and Cognitive Effects of Alcohol When Co-administered With GSK1144814 or Matching Placebo in Healthy Subjects.
The purpose of this study is understand the effects of GSK114814 and alcohol in healthy volunteers when taken together.
Read the detailed description
The primary objective of this study is to investigate the CNS effects of co-administration of GSK1144814 with alcohol. Healthy volunteers who meet the eligibility criteria will be randomized to receive GSK1144814 or placebo with alcohol.
- Conditions
- Alcoholism
- Being tested
- single dose
- Keywords
- alcohol, drug interaction, pharmacodynamic
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single doseDrug
Subjects will receive a single dose of GSK1144814 or placebo.
| Study group | Role | What they receive |
|---|---|---|
| GSK1144814 | Experimental | Subjects will receive either GSK1144814 or placebo at each treatment arm. Receives: Drug: single dose |
| placebo | Placebo comparator | Subjects will receive either GSK1144814 or placebo at each treatment arm. Receives: Drug: single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacodynamic measures for various psychomotor/cognition function and subjective effects
Measured: pre and post study drug administration
Secondary outcomes (3)
alcohol level
Measured: during and post alcohol administration
blood level of GSK1144814
Measured: pre and post study drug administration
safety and tolerability as measured by adverse events, vital signs, clinical laboratory measurements and validated clinical assessment scales
Measured: throughout the study pre- and post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study start11 Nov 2009
- Primary completion30 Dec 2009
- Study completion30 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181908
- Sponsor's protocol ID
- 113476
- Status last verified
- Jun 2017
- First submitted
- 17 Dec 2009
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
te Beek ET, Hay JL, Bullman JN, Burgess C, Nahon KJ, Klaassen ES, Gray FA, van Gerven JM. Pharmacokinetics and central nervous system effects of the novel dual NK1 /NK3 receptor antagonist GSK1144814 in alcohol-intoxicated volunteers. Br J Clin Pharmacol. 2013 May;75(5):1328-39. doi: 10.1111/bcp.12004.
PubMed 23067311
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Psychomotor and Cognitive Effects of Alcohol When Co-administered With GSK1144814 or Matching Placebo in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01181908
- Acronym / sponsor ID
- 113476
- Conditions
- Alcoholism
- Keywords
- alcohol, drug interaction, pharmacodynamic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2009 (actual)
- Primary completion
- 30 Dec 2009 (actual)
- Study completion
- 30 Dec 2009 (actual)
- First posted
- 13 Aug 2010 (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 understand the effects of GSK114814 and alcohol in healthy volunteers when taken together.
Detailed description
The primary objective of this study is to investigate the CNS effects of co-administration of GSK1144814 with alcohol. Healthy volunteers who meet the eligibility criteria will be randomized to receive GSK1144814 or placebo with alcohol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK1144814 | Experimental | Drug: single doseSubjects will receive either GSK1144814 or placebo at each treatment arm. |
| placebo | Placebo comparator | Drug: single doseSubjects will receive either GSK1144814 or placebo at each treatment arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male and female
- Body weight 50 kg or higher and BMI within the range 19 - 29.9 kg/m2
- Willing to use appropriate contraception methods
Key exclusion criteria (11 listed)
- Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody result
- Any serious medical disorder or condition
- Any history of an endocrine disorder.
- Any clinically significant laboratory abnormality.
- History of psychiatric illness.
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 |
|---|---|---|
| single doseSubjects will receive a single dose of GSK1144814 or placebo. | Drug | GSK1144814, placebo |
Primary outcome
pharmacodynamic measures for various psychomotor/cognition function and subjective effects
Time frame: pre and post study drug administration
3 secondary outcomes
alcohol level
Time frame: during and post alcohol administration
blood level of GSK1144814
Time frame: pre and post study drug administration
safety and tolerability as measured by adverse events, vital signs, clinical laboratory measurements and validated clinical assessment scales
Time frame: throughout the study pre- and post dose
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 27 Jun 2017.
- Background: PubMed 23067311te Beek ET, Hay JL, Bullman JN, Burgess C, Nahon KJ, Klaassen ES, Gray FA, van Gerven JM. Pharmacokinetics and central nervous system effects of the novel dual NK1 /NK3 receptor antagonist GSK1144814 in alcohol-intoxicated volunteers. Br J Clin Pharmacol. 2013 May;75(5):1328-39. doi: 10.1111/bcp.12004.
- Results for study 113476 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Alcoholism
RecruitingObservational study
NIAAA Natural History Protocol
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
RecruitingPhase 1
Spironolactone in Alcohol Use Disorder (SAUD)
Alcohol Use Disorder
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.
GSK Clinical Trials study director
GlaxoSmithKline
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 single dose in people with Alcoholism, run by GlaxoSmithKline at 1 site in Netherlands.
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 11 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 27 Jun 2017. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
pharmacodynamic measures for various psychomotor/cognition function and subjective effects (time frame: pre and post study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01181908, which also lists 1 linked publication.
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 27 Jun 2017; AzTrials last refreshed its copy on 27 Oct 2026.