Study 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.
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.
GT1110791
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.
1 other identifier
interventional
34
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 schizophrenia
Started Jul 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 25, 2009
CompletedFirst Posted
Study publicly available on registry
June 29, 2009
CompletedJune 29, 2009
June 1, 2009
3 months
June 25, 2009
June 25, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Part A: Safety and tolerability endpoints consisting of: adverse events; 12-lead ECG; vital signs, clinical laboratory evaluations and PK parameters.
14 days twice daily dosing.
Part B: Midazolam PK following single and repeat doses of GSK1018921.
14 days twice daily dosing.
Part C: Plasma & CSF glycine concentrations following single doses og GSK1018921.
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.
28 days
Secondary Outcomes (4)
Part A: Effects of GSK1018921 on VAS
14 days.
Part B: None
0
Part C: GSK1018921 plasma exposure-CSF glycine relationship
After single dosing.
Part D: Effects of GSK1018921 on VAS, PANSS and CGI
28 days.
Study Arms (1)
GSK1018921
EXPERIMENTALGlycine Transporter-1 inhibitor to modulate the NMDA receptor.
Interventions
GSK1018921 is a potent and selective inhibitor of the glycine transporter-1 (GlyT-1).
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Glendale, California, 91206, United States
GSK Investigational Site
Bellaire, Texas, 77401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 25, 2009
First Posted
June 29, 2009
Study Start
July 1, 2008
Primary Completion
October 1, 2008
Study Completion
March 1, 2009
Last Updated
June 29, 2009
Record last verified: 2009-06