Safety, Blood Levels, Drug Interaction and Effects of Repeated Doses of GSK1034702
Phase 1
Completed
- Conditions
- Cognitive Disorders
- Interventions
- Registration Number
- NCT00950586
- Lead Sponsor
- GlaxoSmithKline
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3 Placebo Up to 28 days repeat dosing with drug interaction Cohort 2 GSK1043702 Single dose followed by 14 days repeat dosing Cohort 1 GSK1043702 14 days dosing Cohort 1 Placebo 14 days dosing Cohort 2 Placebo Single dose followed by 14 days repeat dosing Cohort 3 GSK1043702 Up to 28 days repeat dosing with drug interaction Cohort 3 Dextromethorphan Up to 28 days repeat dosing with drug interaction
- Primary Outcome Measures
Name Time Method 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 GSK1034702 PK parameters: Cmax; tmax; AUC(0-t) Up to 28 days Effects on Cognitive tests. Up to day 28 Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t). Day -2, 1 and 14 Effects on salivary secretion up to 28 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧London, United Kingdom