Safety, Blood Levels, Drug Interaction and Effects of Repeated Doses of GSK1034702

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-24

Study Completion Date

2009-12-24

Brief Summary

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GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia. This study will be done in healthy men and women of no child beading potential to investigate repeated doses of the study medicine. The study will investigate the following questions, do repeated doses of the study medicine have any important side effects when taken by mouth? How much of the study medicine gets into the bloodstream, and how quickly does the body get rid of it? Does the study medicine affect memory, attention and problem-solving skills? What are the effects when the study medicine and dextromethorphan are taken together.

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Detailed Description

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Conditions

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Cognitive Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

14 days dosing

Group Type EXPERIMENTAL

GSK1043702

Intervention Type DRUG

Oral dose in liquid or tablet formulation

Placebo

Intervention Type DRUG

To match GSK1034702

Cohort 2

Single dose followed by 14 days repeat dosing

Group Type EXPERIMENTAL

GSK1043702

Intervention Type DRUG

Oral dose in liquid or tablet formulation

Placebo

Intervention Type DRUG

To match GSK1034702

Cohort 3

Up to 28 days repeat dosing with drug interaction

Group Type EXPERIMENTAL

GSK1043702

Intervention Type DRUG

Oral dose in liquid or tablet formulation

Dextromethorphan

Intervention Type DRUG

30mg Oral dose

Placebo

Intervention Type DRUG

To match GSK1034702

Interventions

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GSK1043702

Oral dose in liquid or tablet formulation

Intervention Type DRUG

Dextromethorphan

30mg Oral dose

Intervention Type DRUG

Placebo

To match GSK1034702

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female of non childbearing potential
* Generally healthy
* Body mass index 19 - 29.9 kg/m2 (inclusive), body weight greater than or equal to 50 kg for males and greater than of equal to 45 kg for females
* Normal Laboratory test results

Exclusion Criteria

* Abuse of drugs or alcohol
* Smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months
* ECG abnormality (personal or family history)
* Psychiatric disorder
* Asthma or a history of asthma
* Medical illness

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Study Documents

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