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.

Stopped early · Phase 1

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT00929370

Run by

GlaxoSmithKline

People needed

34

Starts

2008-07-01

Expected to finish

2009-03-01

Last updated by the study team

2009-06-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• GSK Investigational Site — Glendale, California, United States
• GSK Investigational Site — Bellaire, Texas, United States

Full record on ClinicalTrials.gov

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