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

Study Overview
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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.

Official Title
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A Placebo-controlled, Single-blind, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Drug Interaction of GSK1034702 After Repeat Doses in Healthy Subjects

Conditions
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Cognitive Disorders

Intervention / Treatment
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* Drug: GSK1043702
* Drug: Dextromethorphan
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>14 days dosing | Drug: GSK1043702<br>* Oral dose in liquid or tablet formulation<br>Drug: Placebo<br>* To match GSK1034702<br>|
| Experimental: Cohort 2<br>Single dose followed by 14 days repeat dosing | Drug: GSK1043702<br>* Oral dose in liquid or tablet formulation<br>Drug: Placebo<br>* To match GSK1034702<br>|
| Experimental: Cohort 3<br>Up to 28 days repeat dosing with drug interaction | Drug: GSK1043702<br>* Oral dose in liquid or tablet formulation<br>Drug: Dextromethorphan<br>* 30mg Oral dose<br>Drug: Placebo<br>* To match GSK1034702<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations. |  | Up to 28 days | 
| GSK1034702 PK parameters: Cmax; tmax; AUC(0-t) |  | Up to 28 days | 
| Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t). |  | Day -2, 1 and 14 | 
| Effects on Cognitive tests. |  | Up to day 28 | 
| Effects on salivary secretion |  | up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug interaction, Saftey, Pharmacokinetics, Cognition