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GSK618334 Repeat Dose Study

NCT ID: NCT01036061

Last Updated: 2017-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-28

Study Completion Date

2010-02-17

Brief Summary

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The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.

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Detailed Description

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GSK618334 strongly binds to dopamine type 3 receptors in the human brain and is being developed as an innovative treatment for substance dependence. This study will evaluate the safety, tolerability, blood concentrations and effect following repeated oral doses of GSK618334 in healthy male and female volunteers. The effect of food on a single oral dose of GSK618334 will also be evaluated. Another portion of this study will investigate dopamine type 3 receptor binding in the human brain by PET scan before and after repeated doses of GSK618334.

Conditions

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Substance Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GSK618334 low Dose

GSK618334 Low Dose

Group Type EXPERIMENTAL

GSK618334 Low Dose

Intervention Type DRUG

GSK618334 low dose

GSK618334 PET subjects

Intervention Type DRUG

PET subjects

GSK618334 Medium Dose

GSK618334 medium dose arm

Group Type EXPERIMENTAL

GSK618334 PET subjects

Intervention Type DRUG

PET subjects

GSK618334 Medium Dose

Intervention Type DRUG

Medium Dose

GSK618334 High Dose

GSK618334 High Dose Arm

Group Type EXPERIMENTAL

GSK618334 PET subjects

Intervention Type DRUG

PET subjects

GSK618334 High Dose

Intervention Type DRUG

GSK618334 High Dose

GSK618334 Placebo

Placebo for all 3 dose levels

Group Type EXPERIMENTAL

GSK618334 Low Dose

Intervention Type DRUG

GSK618334 low dose

GSK618334 Medium Dose

Intervention Type DRUG

Medium Dose

GSK618334 High Dose

Intervention Type DRUG

GSK618334 High Dose

Interventions

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GSK618334 Low Dose

GSK618334 low dose

Intervention Type DRUG

GSK618334 PET subjects

PET subjects

Intervention Type DRUG

GSK618334 Medium Dose

Medium Dose

Intervention Type DRUG

GSK618334 High Dose

GSK618334 High Dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Males and Females between the ages of 18-50 years old
* Male and Female subjects must agree to use protocol specified contraceptive methods.
* Male subjects only in PET parts of the study.
* Capable of providing written informed consent.

Exclusion Criteria

* A positive test for Hepatitis B or Hepatitis C within 3 months of screening.
* Current or chronic history of liver disease, or known liver/bile/gallbladder abnormalities.
* Personal or family history of heart disease (such as irregular heart beats, a history of sudden unexplained death in a first degree relative, or unexplained fainting).
* Screening ECG parameters outside the protocol specified parameters.
* Pulse rate \<50 or \>100 bpm OR a systolic blood pressure \>140 or \<95 mmHg OR a diastolic blood pressure \>90 or \<50 mmHg at screening and/or baseline.
* Pregnant or lactating females.
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden.
* Significant suicidal risk.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Study Documents

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Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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108414

Identifier Type: -

Identifier Source: org_study_id

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