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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00950586

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Disorders	Drug: GSK1043702 Drug: Dextromethorphan Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 24, 2009

Actual Primary Completion Date :

Dec 24, 2009

Actual Study Completion Date :

Dec 24, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Cohort 1

14 days dosing

Drug: GSK1043702

Oral dose in liquid or tablet formulation

Drug: Placebo

To match GSK1034702

Experimental: Cohort 2

Single dose followed by 14 days repeat dosing

Drug: GSK1043702

Oral dose in liquid or tablet formulation

Drug: Placebo

To match GSK1034702

Experimental: Cohort 3

Up to 28 days repeat dosing with drug interaction

Drug: GSK1043702

Oral dose in liquid or tablet formulation

Drug: Dextromethorphan

30mg Oral dose

Drug: Placebo

To match GSK1034702

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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