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First Time in Human Study With GSK1018921

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00527020
First Posted: September 10, 2007
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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: GSK1018921 Drug: Nicotine Lozenges Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 27
Actual Study Start Date: August 10, 2007
Study Completion Date: July 12, 2008
Primary Completion Date: July 12, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A: Subjects receiving treatment in cohort A
Eligible subjects will be randomized to receive GSK101892 and placebo. Subjects will receive escalated doses of GSK101892 with a starting dose of 0.5 milligrams. Each subject will receive no more than 4 doses of GSK1018921 in a maximum of 5 dosing sessions. Within each cohort, each session will be separated by a washout period of at least 7 days.
Drug: GSK1018921
GSK1018921 will be supplied as 0.5, 5, 10 and 40 milligrams coated tablets.
Drug: Nicotine Lozenges
Nicotine Lozenges will be supplied as 4 milligrams lozenges.
Drug: Placebo
Placebo tablets will be given to the subjects.
Experimental: Part A: Subjects receiving treatment in cohort B
Eligible subjects will be randomized to receive GSK101892 and placebo. Subjects will receive escalated doses of GSK101892 with a starting dose of 0.5 milligrams. Each subject will receive no more than 4 doses of GSK1018921 in a maximum of 5 dosing sessions. Within each cohort, each session will be separated by a washout period of at least 7 days.
Drug: GSK1018921
GSK1018921 will be supplied as 0.5, 5, 10 and 40 milligrams coated tablets.
Drug: Nicotine Lozenges
Nicotine Lozenges will be supplied as 4 milligrams lozenges.
Drug: Placebo
Placebo tablets will be given to the subjects.
Experimental: Part A: Subjects receiving treatment in cohort C
Eligible subjects will be randomized to receive GSK101892 and placebo. Subjects will receive escalated doses of GSK101892 with a starting dose of 0.5 milligrams. Each subject will receive no more than 4 doses of GSK1018921 in a maximum of 5 dosing sessions. Within each cohort, each session will be separated by a washout period of at least 7 days.
Drug: GSK1018921
GSK1018921 will be supplied as 0.5, 5, 10 and 40 milligrams coated tablets.
Drug: Nicotine Lozenges
Nicotine Lozenges will be supplied as 4 milligrams lozenges.
Drug: Placebo
Placebo tablets will be given to the subjects.
Experimental: Part B: Subjects in 5 period crossover period
Eligible subjects (first 14 subjects) will be randomized to one of the following 14 sequences as a 5 period crossover with sequences; LMNOQ, MNOLQ, NOLMQ, OLMNQ, ONMLQ, NMLOQ, MLONQ, LONMQ, LNMOQ, NMOLQM MOLNQ, OLNMQ, OMNLQ and MNLOQ) (L= 80 milligrams GSK1018921 given in fasted state, M= 200 milligrams GSK1018921 given in fasted state, N= nicotine lozenge, O= placebo and Q= 80 milligrams GSK1018921 in fed state).
Drug: GSK1018921
GSK1018921 will be supplied as 0.5, 5, 10 and 40 milligrams coated tablets.
Drug: Nicotine Lozenges
Nicotine Lozenges will be supplied as 4 milligrams lozenges.
Drug: Placebo
Placebo tablets will be given to the subjects.
Experimental: Part B: Subjects in 4 period crossover period
Eligible subjects (last 7 subjects) will be randomized to one of the following 7 sequences as a 4 period crossover with sequences; NLOM, LOMN, OLNM, LNMO, NMOL, MOLN, and MNLO.
Drug: GSK1018921
GSK1018921 will be supplied as 0.5, 5, 10 and 40 milligrams coated tablets.
Drug: Nicotine Lozenges
Nicotine Lozenges will be supplied as 4 milligrams lozenges.
Drug: Placebo
Placebo tablets will be given to the subjects.

Detailed Description:
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527020


Locations
Germany
GSK Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00527020     History of Changes
Other Study ID Numbers: GT1109727
First Submitted: September 6, 2007
First Posted: September 10, 2007
Last Update Posted: August 4, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
qEEG,
GlyT-1 inhibitor,
ERP
GSK1018921,
FTIH,
schizophrenia,
single-dose,
healthy volunteers,
MMN,

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action