drugset / Trial / NCT00527020

First Time in Human Study With GSK1018921

NCT00527020

Phase 1 Completed 27 enrolled GlaxoSmithKline
RandomizedCrossoverTreatment

Summary

GSK1018921 is a new drug under development for the treatment of schizophrenia. GSK1018921 differs from other available drugs in its mode of action and it is assumed that it may have an effect in the treatment of so-called positive symptoms such as hallucinations and negative symptoms such as lack of drive. No clinical studies have been conducted with GSK1018921 in humans until now. This is the first study where this compound is administered to humans; the study has 2 parts: Part A is a dose escalation study, Part B is a pharmacodynamic portion in a separate group of healthy smoker volunteers.

Timeline

Start
2007-08-10
Primary completion
2008-07-12
Completion
2008-07-12

Publications

  • Background Daniele Ouellet, Suzanne Sutherland, Tianli Wang, Patrizia Griffini, Venkatesha Murthy. First-Time-in-Human Study with GSK1018921, a Selective GlyT1-Inhibitor: Characterization of the Exposure-Response to Dizziness, the Dose Limiting Adverse Event. [Clin Pharmacol Ther]. 2011;DOI: CLPT.2011.154:

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK1018921 Unknown 0.5 mg Oral
Subject GSK1018921 Unknown 5 mg Oral
Subject GSK1018921 Unknown 10 mg Oral
Subject GSK1018921 Unknown 40 mg Oral
Subject GSK1018921 Unknown 80 mg Oral
Subject GSK1018921 Unknown 200 mg Oral
Subject Nicotine Unknown 4 mg

Indications