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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00950586
First received: July 30, 2009
Last updated: August 23, 2012
Last verified: April 2011

July 30, 2009
August 23, 2012
August 2009
December 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 ] [ Designated as safety issue: Yes ]
  • GSK1034702 PK parameters: Cmax; tmax; AUC(0-t) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t). [ Time Frame: Day -2, 1 and 14 ] [ Designated as safety issue: No ]
  • Effects on Cognitive tests. [ Time Frame: Up to day 28 ] [ Designated as safety issue: No ]
  • Effects on salivary secretion [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00950586 on ClinicalTrials.gov Archive Site
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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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Cognitive Disorders
  • Healthy Volunteer
  • 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 2009
December 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
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00950586
110792
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2011

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