Text Size

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
History of Changes
  Purpose

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 Intervention Phase
Cognitive Disorders
Healthy Volunteer
 Drug: GSK1043702
Drug: Dextromethorphan
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

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

Further study details as provided by GlaxoSmithKline:

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. [ 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 ]

Enrollment: 48
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950586

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00950586     History of Changes
Other Study ID Numbers: 110792
Study First Received: July 30, 2009
Last Updated: August 23, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Drug interaction
Saftey
Pharmacokinetics
Cognition

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dextromethorphan
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Respiratory System Agents

ClinicalTrials.gov processed this record on May 16, 2013