Last updated: 11/07/2018 03:04:29

Safety, blood levels, drug interaction and effects of repeated doses of GSK1034702

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GSK study ID
110792
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Clinicaltrials.gov ID
NCT00950586
EudraCT ID
2008-007759-28
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations.

Timeframe: Up to 28 days

GSK1034702 PK parameters: Cmax; tmax; AUC(0-t)

Timeframe: Up to 28 days

Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t).

Timeframe: Day -2, 1 and 14

Effects on Cognitive tests.

Timeframe: Up to day 28

Effects on salivary secretion

Timeframe: up to 28 days

Secondary outcomes:
Not applicable
Interventions:
Drug: GSK1043702
Drug: Dextromethorphan
Drug: Placebo
Enrollment:
48
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Jesper Lund, Gordon Dear, Marty Lowy, Jay Graham.A PLACEBO-CONTROLLED, SINGLE-BLIND, RANDOMISED STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND DRUG INTERACTION OF GSK1034702 (M1 RECEPTOR AGONIST) AFTER REPEAT DOSES IN HEALTHY SUBJECTS FOR UP TO 28 DAYS.Biological Psychiatry.2013;73(9):1S-110S
Medical condition
Cognitive Disorders
Product
GSK1034702
Collaborators
Not applicable
Study date(s)
August 2009 to December 2009
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
Yes
  • Male or female of non childbearing potential
  • Generally healthy
  • Abuse of drugs or alcohol
  • Smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months
Inclusion and exclusion 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

Trial location(s)

Location
Status
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Location
GSK Investigational Site
London, United Kingdom, NW10 7EW
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-24-12

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
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