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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00950586
First Posted: August 3, 2009
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
July 30, 2009
August 3, 2009
July 13, 2017
August 24, 2009
December 24, 2009   (Final data collection date for primary outcome measure)
  • 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 ]
  • GSK1034702 PK parameters: Cmax; tmax; AUC(0-t) [ Time Frame: Up to 28 days ]
  • Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t). [ Time Frame: Day -2, 1 and 14 ]
  • Effects on Cognitive tests. [ Time Frame: Up to day 28 ]
  • Effects on salivary secretion [ Time Frame: up to 28 days ]
  • Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t). [ Time Frame: Day -2, 1 and 14 ]
  • Effects on Cognitive tests. [ Time Frame: Up to day 28 ]
  • Effects on salivary secretion [ Time Frame: up to 28 days ]
  • 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 ]
  • GSK1034702 PK parameters: Cmax; tmax; AUC(0-t). [ Time Frame: Up to 28 days ]
Complete list of historical versions of study NCT00950586 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Cognitive Disorders
  • Drug: GSK1043702
    Oral dose in liquid or tablet formulation
  • Drug: Dextromethorphan
    30mg Oral dose
  • Drug: Placebo
    To match GSK1034702
  • Experimental: Cohort 1
    14 days dosing
    Interventions:
    • Drug: GSK1043702
    • Drug: Placebo
  • Experimental: Cohort 2
    Single dose followed by 14 days repeat dosing
    Interventions:
    • Drug: GSK1043702
    • Drug: Placebo
  • Experimental: Cohort 3
    Up to 28 days repeat dosing with drug interaction
    Interventions:
    • Drug: GSK1043702
    • Drug: Dextromethorphan
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 24, 2009
December 24, 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00950586
110792
No
Not Provided
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://
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP