Substance DependencePhase 1NCT01036061
GSK618334 Repeat Dose Study
A Phase 1 study testing GSK618334 Low Dose, GSK618334 PET subjects and GSK618334 Medium Dose in people with Substance Dependence, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Dependence
- What is being tested?
- GSK618334 Low Dose, GSK618334 PET subjects and GSK618334 Medium Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Sep 2009to 17 Feb 2010
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Males and Females between the ages of 18-50 years old
- Male and Female subjects must agree to use protocol specified contraceptive methods.
- Male subjects only in PET parts of the study.
- Capable of providing written informed consent.
Who cannot join
- A positive test for Hepatitis B or Hepatitis C within 3 months of screening.
- Current or chronic history of liver disease, or known liver/bile/gallbladder abnormalities.
- Personal or family history of heart disease (such as irregular heart beats, a history of sudden unexplained death in a first degree relative, or unexplained fainting).
- Screening ECG parameters outside the protocol specified parameters.
- Pulse rate <50 or >100 bpm OR a systolic blood pressure >140 or <95 mmHg OR a diastolic blood pressure >90 or <50 mmHg at screening and/or baseline.
- Pregnant or lactating females.
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- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden.
- Significant suicidal risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled, Single Blind, Randomized Two Part Study Toinvestigate the Tolerability, Pharmacokinetics, and brainDopamine D3 Receptor Occupancy of Increasing Repeat Doses ofGSK618334 for up to 21 Days in Healthy Volunteers.
The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.
Read the detailed description
GSK618334 strongly binds to dopamine type 3 receptors in the human brain and is being developed as an innovative treatment for substance dependence. This study will evaluate the safety, tolerability, blood concentrations and effect following repeated oral doses of GSK618334 in healthy male and female volunteers. The effect of food on a single oral dose of GSK618334 will also be evaluated. Another portion of this study will investigate dopamine type 3 receptor binding in the human brain by PET scan before and after repeated doses of GSK618334.
- Conditions
- Substance Dependence
- Being tested
- GSK618334 Low Dose, GSK618334 PET subjects, GSK618334 Medium Dose, GSK618334 High Dose
- Keywords
- compulsive discorders, addiction
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK618334 Low DoseDrug
GSK618334 low dose
GSK618334 PET subjectsDrug
PET subjects
GSK618334 Medium DoseDrug
Medium Dose
GSK618334 High DoseDrug
GSK618334 High Dose
| Study group | Role | What they receive |
|---|---|---|
| GSK618334 low Dose | Experimental | GSK618334 Low Dose Receives: Drug: GSK618334 Low Dose; Drug: GSK618334 PET subjects |
| GSK618334 Medium Dose | Experimental | GSK618334 medium dose arm Receives: Drug: GSK618334 PET subjects; Drug: GSK618334 Medium Dose |
| GSK618334 High Dose | Experimental | GSK618334 High Dose Arm Receives: Drug: GSK618334 PET subjects; Drug: GSK618334 High Dose |
| GSK618334 Placebo | Experimental | Placebo for all 3 dose levels Receives: Drug: GSK618334 Low Dose; Drug: GSK618334 Medium Dose; Drug: GSK618334 High Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability endpoints will be: adverse events, laboratory values, cardiovascular variables (blood pressure, heart rate, ECG), temperature, respiratory rate, assessment of mood and abnormal movements, and GSK618334 blood levels.
Measured: First dose to follow-up
To assess blood concentrations of GSK618334 after repeated oral doses.
Measured: First dose to 72 hours post last dose
Secondary outcomes (2)
To assess the effect of food on GSK618334 blood concentrations after a single dose.
Measured: First dose of the single dose session to 24 hours after dosing of the repeat dose session
The dopamine type 3 receptor binding in the brain (by PET scan) of GSK618334 following the repeat dose session.
Measured: First dose to 24 hours after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study start28 Sep 2009
- Primary completion17 Feb 2010
- Study completion17 Feb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance DependenceStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 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
- NCT01036061
- Sponsor's protocol ID
- 108414
- Status last verified
- Jun 2017
- First submitted
- 17 Dec 2009
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Single Blind, Randomized Two Part Study Toinvestigate the Tolerability, Pharmacokinetics, and brainDopamine D3 Receptor Occupancy of Increasing Repeat Doses ofGSK618334 for up to 21 Days in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01036061
- Acronym / sponsor ID
- 108414
- Conditions
- Substance Dependence
- Keywords
- compulsive discorders, addiction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2009 (actual)
- Primary completion
- 17 Feb 2010 (actual)
- Study completion
- 17 Feb 2010 (actual)
- First posted
- 21 Dec 2009 (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 proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.
Detailed description
GSK618334 strongly binds to dopamine type 3 receptors in the human brain and is being developed as an innovative treatment for substance dependence. This study will evaluate the safety, tolerability, blood concentrations and effect following repeated oral doses of GSK618334 in healthy male and female volunteers. The effect of food on a single oral dose of GSK618334 will also be evaluated. Another portion of this study will investigate dopamine type 3 receptor binding in the human brain by PET scan before and after repeated doses of GSK618334.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GSK618334 low Dose | Experimental | Drug: GSK618334 Low Dose, Drug: GSK618334 PET subjectsGSK618334 Low Dose |
| GSK618334 Medium Dose | Experimental | Drug: GSK618334 PET subjects, Drug: GSK618334 Medium DoseGSK618334 medium dose arm |
| GSK618334 High Dose | Experimental | Drug: GSK618334 PET subjects, Drug: GSK618334 High DoseGSK618334 High Dose Arm |
| GSK618334 Placebo | Experimental | Drug: GSK618334 Low Dose, Drug: GSK618334 Medium Dose, Drug: GSK618334 High DosePlacebo for all 3 dose levels |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Males and Females between the ages of 18-50 years old
- Male and Female subjects must agree to use protocol specified contraceptive methods.
- Male subjects only in PET parts of the study.
- Capable of providing written informed consent.
Key exclusion criteria (10 listed)
- A positive test for Hepatitis B or Hepatitis C within 3 months of screening.
- Current or chronic history of liver disease, or known liver/bile/gallbladder abnormalities.
- Personal or family history of heart disease (such as irregular heart beats, a history of sudden unexplained death in a first degree relative, or unexplained fainting).
- Screening ECG parameters outside the protocol specified parameters.
- Pulse rate <50 or >100 bpm OR a systolic blood pressure >140 or <95 mmHg OR a diastolic blood pressure >90 or <50 mmHg at screening and/or baseline.
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 |
|---|---|---|
| GSK618334 Low DoseGSK618334 low dose | Drug | GSK618334 Placebo, GSK618334 low Dose |
| GSK618334 PET subjectsPET subjects | Drug | GSK618334 High Dose, GSK618334 Medium Dose, GSK618334 low Dose |
| GSK618334 Medium DoseMedium Dose | Drug | GSK618334 Medium Dose, GSK618334 Placebo |
| GSK618334 High DoseGSK618334 High Dose | Drug | GSK618334 High Dose, GSK618334 Placebo |
Primary outcome
The safety and tolerability endpoints will be: adverse events, laboratory values, cardiovascular variables (blood pressure, heart rate, ECG), temperature, respiratory rate, assessment of mood and abnormal movements, and GSK618334 blood levels.
Time frame: First dose to follow-up
To assess blood concentrations of GSK618334 after repeated oral doses.
Time frame: First dose to 72 hours post last dose
2 secondary outcomes
To assess the effect of food on GSK618334 blood concentrations after a single dose.
Time frame: First dose of the single dose session to 24 hours after dosing of the repeat dose session
The dopamine type 3 receptor binding in the brain (by PET scan) of GSK618334 following the repeat dose session.
Time frame: First dose to 24 hours after last 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 22 Jun 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 108414 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
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 GSK618334 Low Dose, GSK618334 PET subjects and GSK618334 Medium Dose in people with Substance Dependence, run by GlaxoSmithKline at 1 site in United Kingdom.
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 4 inclusion and 10 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 22 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 United Kingdom. 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?
The safety and tolerability endpoints will be: adverse events, laboratory values, cardiovascular variables (blood pressure, heart rate, ECG), temperature, respiratory rate, assessment of mood and abnormal movements, and GSK618334 blood levels. (time frame: First dose to follow-up). The study lists 2 primary outcomes in all. 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 22 Jun 2017.