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

Cognitive Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950586
• Other study ID #: 110792
• Status: Completed
• Phase: Phase 1
• First received: July 30, 2009
• Last updated: July 11, 2017
• Start date: August 24, 2009
• Est. completion date: December 24, 2009

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 24, 2009
• Est. primary completion date: December 24, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorders

Intervention

Drug:
• GSK1043702
Oral dose in liquid or tablet formulation
• Dextromethorphan
30mg Oral dose
• Placebo
To match GSK1034702

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations.		Up to 28 days
Primary	GSK1034702 PK parameters: Cmax; tmax; AUC(0-t)		Up to 28 days
Primary	Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t).		Day -2, 1 and 14
Primary	Effects on Cognitive tests.		Up to day 28
Primary	Effects on salivary secretion		up to 28 days

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 110792 can be found on the GSK Clinical Study Register.