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

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Disorders
• Intervention / Treatment: Drug: Placebo; Drug: GSK1043702; Drug: Dextromethorphan

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW10 7EW
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2009
• Primary Completion (Actual): December 24, 2009
• Study Completion (Actual): December 24, 2009

Study Registration Dates

• First Submitted: July 30, 2009
• First Submitted That Met QC Criteria: July 30, 2009
• First Posted (Estimate): August 3, 2009

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Cognition; Drug interaction; Saftey
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Respiratory System Agents; Antitussive Agents; Dextromethorphan
• Other Study ID Numbers: 110792

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Study Data/Documents

1. Statistical Analysis Plan
   Information identifier: 110792
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Informed Consent Form
   Information identifier: 110792
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 110792
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 110792
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Annotated Case Report Form
   Information identifier: 110792
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: 110792
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Dataset Specification
   Information identifier: 110792
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register