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

A Placebo-controlled, Single-blind, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Drug Interaction of GSK1034702 After Repeat Doses in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00950586

Enrollment

Registered

2009-08-03

Start date

2009-08-24

Completion date

2009-12-24

Last updated

2017-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Disorders

Keywords

Drug interaction, Saftey, Pharmacokinetics, Cognition

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.

Interventions

DRUGGSK1043702

Oral dose in liquid or tablet formulation

DRUGDextromethorphan

30mg Oral dose

DRUGPlacebo

To match GSK1034702

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame
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
Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t).	Day -2, 1 and 14
Effects on Cognitive tests.	Up to day 28
Effects on salivary secretion	up to 28 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026