Status:
TERMINATED
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.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
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 ...
Eligibility Criteria
Inclusion
- All subjects (Healthy and Patients)
- Exclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00929370
Start Date
July 1 2008
End Date
March 1 2009
Last Update
June 29 2009
Active Locations (2)
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1
GSK Investigational Site
Glendale, California, United States, 91206
2
GSK Investigational Site
Bellaire, Texas, United States, 77401