Last updated: 11/04/2018 07:59:55
First Time in Human Study with GSK1018921
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: pre-dose-8-15days post dose
Secondary outcomes:
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
Timeframe: pre-dose-8-15 days post dose
Interventions:
Drug: GSK1018921
Drug: Nicotine Lozenges
Drug: Placebo
Enrollment:
27
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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:
Medical condition
Schizophrenia
Product
GSK1018921
Collaborators
Not applicable
Study date(s)
August 2007 to July 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-12-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study GT1109727 can be found on the GSK Clinical Study Register.
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