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 Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Cohort 1
14 days dosing
Intervention: GSK1043702 (Drug)
Cohort 1
14 days dosing
Intervention: Placebo (Drug)
Cohort 2
Single dose followed by 14 days repeat dosing
Intervention: GSK1043702 (Drug)
Cohort 2
Single dose followed by 14 days repeat dosing
Intervention: Placebo (Drug)
Cohort 3
Up to 28 days repeat dosing with drug interaction
Intervention: GSK1043702 (Drug)
Cohort 3
Up to 28 days repeat dosing with drug interaction
Intervention: Dextromethorphan (Drug)
Cohort 3
Up to 28 days repeat dosing with drug interaction
Intervention: Placebo (Drug)
Outcomes
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.
Time Frame: Up to 28 days
GSK1034702 PK parameters: Cmax; tmax; AUC(0-t)
Time Frame: Up to 28 days
Effects on Cognitive tests.
Time Frame: Up to day 28
Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t).
Time Frame: Day -2, 1 and 14
Effects on salivary secretion
Time Frame: up to 28 days
Secondary Outcomes
No secondary outcomes reported