First Time in Human Study With GSK1018921
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: active Comparator Nicotine Drug: GSK1018921 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | See Detailed Description |
- 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 ]
- 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 ]
| Estimated Enrollment: | 54 |
| Study Start Date: | August 2007 |
-
Drug: active Comparator Nicotine
Drug: GSK1018921
- active Comparator Nicotine
- 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 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
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00527020 History of Changes |
| Other Study ID Numbers: | GT1109727 |
| Study First Received: | September 6, 2007 |
| Last Updated: | March 15, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by GlaxoSmithKline:
|
qEEG, GlyT-1 inhibitor, healthy volunteers, ERP FTIH, |
MMN, GSK1018921, schizophrenia, single-dose, |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013