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First Time in Human Study With GSK1018921

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00527020
First received: September 6, 2007
Last updated: February 1, 2017
Last verified: February 2011

September 6, 2007
February 1, 2017
August 2007
July 2008   (Final data collection date for primary outcome measure)
Part A:Safety pre-dose-8-15days post dose Tolerability,PK of single escalating doses. Part B: PD effects of single doses of GSK1018921 and nicotine on Quantitative Electroencephalography and MisMatch Negativity in smokers. [ Time Frame: pre-dose-8-15days post dose ]
Same as current
Complete list of historical versions of study NCT00527020 on ClinicalTrials.gov Archive Site
Part A:Characterise single-dose PD with Bond-Lader Visual analogue Scale,Profile of Mood State,Glycine levels.Part B:Safety pre-dose-8-15 days post dose,Tolerability,PK of single escalating doses.Amplitude and latency of P300, Effects on P50 suppression [ Time Frame: pre-dose-8-15 days post dose ]
Same as current
Not Provided
Not Provided
 
First Time in Human Study With GSK1018921
Single-Blind, Randomised, Placebo-controlled First Time in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Escalating Doses of GSK1018921 in Healty Volunteers and a Randomized, Double-blind, Double Dummy, Placebo Controlled, Three-way Crossover Study in a Separate Cohort of Healthy Volunteers to Test the Effect of Single Doses of GSK1018921 and Nicotine on qEEG and MMN in Healthy Volunteers
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.
Single-Blind, Randomised, Placebo-Controlled First Time in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Escalating Doses of GSK1018921 in Healthy Volunteers and to assess the effect of a single dose of GSK1018921 on quantitative EEG and Mismatch Negativity in a separate cohort of healthy smoker volunteers
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
Schizophrenia
  • Drug: GSK1018921
  • Other: Nicotine
  • GSK1018921
    GSK1018921
    Intervention: Drug: GSK1018921
  • Active Comparator: Nicotine
    Intervention: Other: Nicotine
Ouellet D, Sutherland S, Wang T, Griffini P, Murthy V. First-time-in-human study with GSK1018921, a selective GlyT1 inhibitor: relationship between exposure and dizziness. Clin Pharmacol Ther. 2011 Oct;90(4):597-604. doi: 10.1038/clpt.2011.154.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
July 2008
July 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
  • For Part B, smokers.

Exclusion Criteria:

  • Part A: Smokers, any subject who takes any prescribed or non-prescribed medication/vitamins specified as prohibited in the protocol, substance abuse, clinically significant disease as determined by a responsible physician.
  • Part B: Non-Smokers
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00527020
GT1109727
No
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP