First Time in Human Study With GSK1018921

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-10

Study Completion Date

2008-07-12

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Study Groups

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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.

Group Type EXPERIMENTAL

GSK1018921

Intervention Type DRUG

GSK1018921 will be supplied as 0.5, 5, 10 and 40 milligrams coated tablets.

Nicotine Lozenges

Intervention Type DRUG

Nicotine Lozenges will be supplied as 4 milligrams lozenges.

Placebo

Intervention Type DRUG

Placebo tablets will be given to the subjects.

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.

Group Type EXPERIMENTAL

GSK1018921

Intervention Type DRUG

GSK1018921 will be supplied as 0.5, 5, 10 and 40 milligrams coated tablets.

Nicotine Lozenges

Intervention Type DRUG

Nicotine Lozenges will be supplied as 4 milligrams lozenges.

Placebo

Intervention Type DRUG

Placebo tablets will be given to the subjects.

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.

Group Type EXPERIMENTAL

GSK1018921

Intervention Type DRUG

GSK1018921 will be supplied as 0.5, 5, 10 and 40 milligrams coated tablets.

Nicotine Lozenges

Intervention Type DRUG

Nicotine Lozenges will be supplied as 4 milligrams lozenges.

Placebo

Intervention Type DRUG

Placebo tablets will be given to the subjects.

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).

Group Type EXPERIMENTAL

GSK1018921

Intervention Type DRUG

GSK1018921 will be supplied as 0.5, 5, 10 and 40 milligrams coated tablets.

Nicotine Lozenges

Intervention Type DRUG

Nicotine Lozenges will be supplied as 4 milligrams lozenges.

Placebo

Intervention Type DRUG

Placebo tablets will be given to the subjects.

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.

Group Type EXPERIMENTAL

GSK1018921

Intervention Type DRUG

GSK1018921 will be supplied as 0.5, 5, 10 and 40 milligrams coated tablets.

Nicotine Lozenges

Intervention Type DRUG

Nicotine Lozenges will be supplied as 4 milligrams lozenges.

Placebo

Intervention Type DRUG

Placebo tablets will be given to the subjects.

Interventions

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GSK1018921

GSK1018921 will be supplied as 0.5, 5, 10 and 40 milligrams coated tablets.

Intervention Type DRUG

Nicotine Lozenges

Nicotine Lozenges will be supplied as 4 milligrams lozenges.

Intervention Type DRUG

Placebo

Placebo tablets will be given to the subjects.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes