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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Cognitive Disorders

Treatments: Drug: GSK1043702; Drug: Placebo; Drug: Dextromethorphan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00950586

110792

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

48 participants in 3 patient groups

Cohort 1

Experimental group

Description:

14 days dosing

Treatment:

Drug: Placebo

Drug: GSK1043702

Cohort 2

Experimental group

Description:

Single dose followed by 14 days repeat dosing

Treatment:

Drug: Placebo

Drug: GSK1043702

Cohort 3

Experimental group

Description:

Up to 28 days repeat dosing with drug interaction

Treatment:

Drug: Placebo

Drug: GSK1043702

Drug: Dextromethorphan