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

NCT00950586 | Completed Phase 1

• 1 other identifier: 110792
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Disorders

Keywords

Drug interaction; Saftey; Pharmacokinetics; Cognition

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Cohort 1

EXPERIMENTAL

14 days dosing

Drug: GSK1043702; Drug: Placebo

Cohort 2

EXPERIMENTAL

Single dose followed by 14 days repeat dosing

Drug: GSK1043702; Drug: Placebo

Cohort 3

EXPERIMENTAL

Up to 28 days repeat dosing with drug interaction

Drug: GSK1043702; Drug: Dextromethorphan; Drug: Placebo

Interventions

GSK1043702 DRUG

Oral dose in liquid or tablet formulation

Cohort 1; Cohort 2; Cohort 3

Dextromethorphan DRUG

30mg Oral dose

Cohort 3

Placebo DRUG

To match GSK1034702

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, NW10 7EW, United Kingdom

Location

Related 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.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: August 3, 2009
• Study Start: August 24, 2009
• Primary Completion: December 24, 2009
• Study Completion: December 24, 2009
• Last Updated: July 13, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)