SchizophreniaPhase 1GT1110791NCT00929370
A Repeat Dose Study With GSK1018921 to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics in Healthy Volunteers and Patients With Schizophrenia and to Evaluate Its Effect on PK of Midazolam.
A Phase 1 study testing Glycine Transporter-1 inhibitor in people with Schizophrenia, run by GlaxoSmithKline at 2 sites in United States.
Trial summary
The purpose of this study is to understand safety and tolerability of the drug GSK1018921 after 14 days of dosing in healthy volunteers and then in patient volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Glycine Transporter-1 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Mar 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- History of drug or alcohol abuse.
- Consumption of drug, food or drink affecting the CYP450 metabolism pathway.
- Has received investigational drug within 30 days to 5 half lives or twice the duration of the biological effect of any drug (which ever is the longer).
- Donation of blood in excess of 500mL within a 56 day period.
- Patients eligibility
- Stable patients with schizophrenia.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Bellaire, Texas, 77401
GSK Investigational Site
Glendale, California, 91206
About this study
Official title: A 4-Part Parallel Group, Randomized, Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Repeat Doses of GSK1018921 in Healthy Volunteers and Stable Patients With Schizophrenia and to Evaluate Its Effects on Pharmacokinetics of Midazolam.
The purpose of this study is to understand safety and tolerability of the drug GSK1018921 after 14 days of dosing in healthy volunteers and then in patient volunteers.
Read the detailed description
This is a four part, parallel group, randomised, study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of repeat doses of GSK1018921 in healthy volunteers and stable patients with schizophrenia and to evaluate its effect on pharmacokinetics of midazolam. Part A will evaluate 14 days repeat BID dosing in at least three cohorts of healthy volunteers, to assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK1018921. Part B will study the potential drug interaction of GSK1018921 (Maximum Tolerated Dose from Part A) with midazolam with 14 days repeat BID dosing in healthy volunteers and therefore will assess the PK, safety and tolerability. Part C will be a single dose study in healthy volunteers and will include CSF sampling to assess the concentration of GSK1018921 and glycine in CSF with two doses (80 and 200 mg). Part D will study stable patients with schizophrenia, to assess safety, tolerability, PK and PD following 28 days of repeat BID dosing.
Safety assessments will include physical examination, 12-lead ECGs, holter monitoring, vital signs, orthostatic vital signs, visual assessments, and clinical lab test. Tolerability will be assessed by collecting Adverse Events.
PD assessments will include glycine in red blood cells, plasma and CSF, as well as CogState Battery test, Visual Assessment Scale, Positive And Negative Symptom Scores (PANSS) and Clinical Global Impression scales of change.
- Conditions
- Schizophrenia
- Being tested
- Glycine Transporter-1 inhibitor
- Keywords
- Schizophrenia, GSK1018921, GlyT-1 inhibitor, Healthy Volunteers, CSF, Patient, Midazolam
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycine Transporter-1 inhibitorDrug
GSK1018921 is a potent and selective inhibitor of the glycine transporter-1 (GlyT-1).
| Study group | Role | What they receive |
|---|---|---|
| GSK1018921 | Experimental | Glycine Transporter-1 inhibitor to modulate the NMDA receptor. Receives: Drug: Glycine Transporter-1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Safety and tolerability endpoints consisting of: adverse events; 12-lead ECG; vital signs, clinical laboratory evaluations and PK parameters.
Measured: 14 days twice daily dosing.
Part B: Midazolam PK following single and repeat doses of GSK1018921.
Measured: 14 days twice daily dosing.
Part C: Plasma & CSF glycine concentrations following single doses og GSK1018921.
Measured: After single dosing.
Part D: Safety and tolerability endpoints consisting of: adverse events; 12-lead ECG; vital signs, clinical laboratory evaluations and movement scales Simpson Angus Scale, AIMS and Barnes akathisia Scale.
Measured: 28 days
Secondary outcomes (4)
Part A: Effects of GSK1018921 on VAS
Measured: 14 days.
Part B: None
Measured: 0
Part C: GSK1018921 plasma exposure-CSF glycine relationship
Measured: After single dosing.
Part D: Effects of GSK1018921 on VAS, PANSS and CGI
Measured: 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startJul 2008
- Primary completionOct 2008
- Study completionMar 2009
Why it stopped: Study has now been terminated due to changes in project strategy. Current available data will be analysed and reported in a synoptic study report.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929370
- Sponsor's protocol ID
- 110791
- Acronym
- GT1110791
- Status last verified
- Jun 2009
- First submitted
- 25 Jun 2009
- Last updated
- 29 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Part Parallel Group, Randomized, Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Repeat Doses of GSK1018921 in Healthy Volunteers and Stable Patients With Schizophrenia and to Evaluate Its Effects on Pharmacokinetics of Midazolam.
- ClinicalTrials.gov ID
- NCT00929370
- Acronym / sponsor ID
- GT1110791 / 110791
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, GSK1018921, GlyT-1 inhibitor, Healthy Volunteers, CSF, Patient, Midazolam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has now been terminated due to changes in project strategy. Current available data will be analysed and reported in a synoptic study report.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 29 Jun 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 purpose of this study is to understand safety and tolerability of the drug GSK1018921 after 14 days of dosing in healthy volunteers and then in patient volunteers.
Detailed description
This is a four part, parallel group, randomised, study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of repeat doses of GSK1018921 in healthy volunteers and stable patients with schizophrenia and to evaluate its effect on pharmacokinetics of midazolam. Part A will evaluate 14 days repeat BID dosing in at least three cohorts of healthy volunteers, to assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK1018921. Part B will study the potential drug interaction of GSK1018921 (Maximum Tolerated Dose from Part A) with midazolam with 14 days repeat BID dosing in healthy volunteers and therefore will assess the PK, safety and tolerability. Part C will be a single dose study in healthy volunteers and will include CSF sampling to assess the concentration of GSK1018921 and glycine in CSF with two doses (80 and 200 mg). Part D will study stable patients with schizophrenia, to assess safety, tolerability, PK and PD following 28 days of repeat BID dosing.
Safety assessments will include physical examination, 12-lead ECGs, holter monitoring, vital signs, orthostatic vital signs, visual assessments, and clinical lab test. Tolerability will be assessed by collecting Adverse Events.
PD assessments will include glycine in red blood cells, plasma and CSF, as well as CogState Battery test, Visual Assessment Scale, Positive And Negative Symptom Scores (PANSS) and Clinical Global Impression scales of change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK1018921 | Experimental | Drug: Glycine Transporter-1 inhibitorGlycine Transporter-1 inhibitor to modulate the NMDA receptor. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- History of drug or alcohol abuse.
- Consumption of drug, food or drink affecting the CYP450 metabolism pathway.
- Has received investigational drug within 30 days to 5 half lives or twice the duration of the biological effect of any drug (which ever is the longer).
- Donation of blood in excess of 500mL within a 56 day period.
- Patients eligibility
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 |
|---|---|---|
| Glycine Transporter-1 inhibitorGSK1018921 is a potent and selective inhibitor of the glycine transporter-1 (GlyT-1). | Drug | GSK1018921 |
Primary outcome
Part A: Safety and tolerability endpoints consisting of: adverse events; 12-lead ECG; vital signs, clinical laboratory evaluations and PK parameters.
Time frame: 14 days twice daily dosing.
Part B: Midazolam PK following single and repeat doses of GSK1018921.
Time frame: 14 days twice daily dosing.
Part C: Plasma & CSF glycine concentrations following single doses og GSK1018921.
Time frame: After single dosing.
Part D: Safety and tolerability endpoints consisting of: adverse events; 12-lead ECG; vital signs, clinical laboratory evaluations and movement scales Simpson Angus Scale, AIMS and Barnes akathisia Scale.
Time frame: 28 days
4 secondary outcomes
Part A: Effects of GSK1018921 on VAS
Time frame: 14 days.
Part B: None
Time frame: 0
Part C: GSK1018921 plasma exposure-CSF glycine relationship
Time frame: After single dosing.
Part D: Effects of GSK1018921 on VAS, PANSS and CGI
Time frame: 28 days.
Results and safety
The study was stopped early (reason given: Study has now been terminated due to changes in project strategy. Current available data will be analysed and reported in a synoptic study report.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2009.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glycine Transporter-1 inhibitor in people with Schizophrenia, run by GlaxoSmithKline at 2 sites 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 0 inclusion and 6 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: stopped early, as of the sponsor's last update on 29 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Study has now been terminated due to changes in project strategy. Current available data will be analysed and reported in a synoptic study report.). Results are not available in the source record.
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?
Part A: Safety and tolerability endpoints consisting of: adverse events; 12-lead ECG; vital signs, clinical laboratory evaluations and PK parameters. (time frame: 14 days twice daily dosing.). The study lists 4 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 29 Jun 2009; AzTrials last refreshed its copy on 1 Nov 2026.