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GSK618334 Repeat Dose Study

Primary Purpose

Substance Dependence

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

GSK618334 Low Dose

GSK618334 PET subjects

GSK618334 Medium Dose

GSK618334 High Dose

About this trial

This is an interventional other trial for Substance Dependence focused on measuring compulsive discorders, addiction

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

GSK618334 low Dose

GSK618334 Medium Dose

GSK618334 High Dose

GSK618334 Placebo

Arm Description

GSK618334 Low Dose

GSK618334 medium dose arm

GSK618334 High Dose Arm

Placebo for all 3 dose levels

Outcomes

Primary Outcome Measures

The safety and tolerability endpoints will be: adverse events, laboratory values, cardiovascular variables (blood pressure, heart rate, ECG), temperature, respiratory rate, assessment of mood and abnormal movements, and GSK618334 blood levels.

To assess blood concentrations of GSK618334 after repeated oral doses.

Secondary Outcome Measures

To assess the effect of food on GSK618334 blood concentrations after a single dose.

The dopamine type 3 receptor binding in the brain (by PET scan) of GSK618334 following the repeat dose session.

Full Information

NCT ID

NCT01036061

First Posted

December 17, 2009

Last Updated

June 21, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01036061

Brief Title

GSK618334 Repeat Dose Study

Official Title

A Placebo-controlled, Single Blind, Randomized Two Part Study Toinvestigate the Tolerability, Pharmacokinetics, and brainDopamine D3 Receptor Occupancy of Increasing Repeat Doses ofGSK618334 for up to 21 Days in Healthy Volunteers.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

September 28, 2009 (Actual)

Primary Completion Date

February 17, 2010 (Actual)

Study Completion Date

February 17, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Dependence

Keywords

compulsive discorders, addiction

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK618334 low Dose

Arm Type

Experimental

Arm Description

GSK618334 Low Dose

Arm Title

GSK618334 Medium Dose

Arm Type

Experimental

Arm Description

GSK618334 medium dose arm

Arm Title

GSK618334 High Dose

Arm Type

Experimental

Arm Description

GSK618334 High Dose Arm

Arm Title

GSK618334 Placebo

Arm Type

Experimental

Arm Description

Placebo for all 3 dose levels

Intervention Type

Drug

Intervention Name(s)

GSK618334 Low Dose

Intervention Description

GSK618334 low dose

Intervention Type

Drug

Intervention Name(s)

GSK618334 PET subjects

Intervention Description

PET subjects

Intervention Type

Drug

Intervention Name(s)

GSK618334 Medium Dose

Intervention Description

Medium Dose

Intervention Type

Drug

Intervention Name(s)

GSK618334 High Dose

Intervention Description

GSK618334 High Dose

Primary Outcome Measure Information:

Title

Time Frame

First dose to follow-up

Title

To assess blood concentrations of GSK618334 after repeated oral doses.

Time Frame

First dose to 72 hours post last dose

Secondary Outcome Measure Information:

Title

To assess the effect of food on GSK618334 blood concentrations after a single dose.

Time Frame

First dose of the single dose session to 24 hours after dosing of the repeat dose session

Title

The dopamine type 3 receptor binding in the brain (by PET scan) of GSK618334 following the repeat dose session.

Time Frame

First dose to 24 hours after last dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

NW10 7EW

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Links:

URL

https://www.clinicalstudydatarequest.com

Description

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

Available IPD and Supporting Information:

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108414

Available IPD/Information Comments

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

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108414

Available IPD/Information Comments

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

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108414

Available IPD/Information Comments

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

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108414

Available IPD/Information Comments

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

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108414

Available IPD/Information Comments

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

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108414

Available IPD/Information Comments

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

Learn more about this trial

GSK618334 Repeat Dose Study

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