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

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ClinicalTrials.gov Identifier: NCT00950586
Recruitment Status : Completed
First Posted : August 3, 2009
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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 Type : Interventional  (Clinical Trial)
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 : August 24, 2009
Actual Primary Completion Date : December 24, 2009
Actual Study Completion Date : December 24, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]
  2. GSK1034702 PK parameters: Cmax; tmax; AUC(0-t) [ Time Frame: Up to 28 days ]
  3. Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t). [ Time Frame: Day -2, 1 and 14 ]
  4. Effects on Cognitive tests. [ Time Frame: Up to day 28 ]
  5. Effects on salivary secretion [ Time Frame: up to 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950586


Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 110792
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 110792
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 110792
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 110792
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 110792
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 110792
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 110792
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00950586     History of Changes
Other Study ID Numbers: 110792
First Posted: August 3, 2009    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: http://

Keywords provided by GlaxoSmithKline:
Drug interaction
Saftey
Pharmacokinetics
Cognition

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs