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

Primary Purpose

Cognitive Disorders

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
GSK1043702
Dextromethorphan
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Disorders focused on measuring Drug interaction, Saftey, Pharmacokinetics, Cognition

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

14 days dosing

Single dose followed by 14 days repeat dosing

Up to 28 days repeat dosing with drug interaction

Outcomes

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.
GSK1034702 PK parameters: Cmax; tmax; AUC(0-t)
Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t).
Effects on Cognitive tests.
Effects on salivary secretion

Secondary Outcome Measures

Full Information

First Posted
July 30, 2009
Last Updated
July 11, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00950586
Brief Title
Safety, Blood Levels, Drug Interaction and Effects of Repeated Doses of GSK1034702
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 24, 2009 (Actual)
Primary Completion Date
December 24, 2009 (Actual)
Study Completion Date
December 24, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Disorders
Keywords
Drug interaction, Saftey, Pharmacokinetics, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
14 days dosing
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Single dose followed by 14 days repeat dosing
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Up to 28 days repeat dosing with drug interaction
Intervention Type
Drug
Intervention Name(s)
GSK1043702
Intervention Description
Oral dose in liquid or tablet formulation
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Intervention Description
30mg Oral dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
To match GSK1034702
Primary Outcome Measure Information:
Title
Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations.
Time Frame
Up to 28 days
Title
GSK1034702 PK parameters: Cmax; tmax; AUC(0-t)
Time Frame
Up to 28 days
Title
Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t).
Time Frame
Day -2, 1 and 14
Title
Effects on Cognitive tests.
Time Frame
Up to day 28
Title
Effects on salivary secretion
Time Frame
up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
NW10 7EW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110792
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110792
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110792
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110792
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110792
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110792
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110792
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

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

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