GSK618334 Repeat Dose Study - Full Text View

Purpose

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

Condition	Intervention	Phase
Substance Dependence Alcoholism Compulsive Disorder	Drug: GSK618334 Low Dose Drug: GSK618334 PET subjects Drug: GSK618334 Medium Dose Drug: GSK618334 High Dose	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator)
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.

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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. [ Time Frame: First dose to follow-up ] [ Designated as safety issue: Yes ]
To assess blood concentrations of GSK618334 after repeated oral doses. [ Time Frame: First dose to 72 hours post last dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	46
Study Start Date:	September 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GSK618334 low Dose GSK618334 Low Dose	Drug: GSK618334 Low Dose GSK618334 low dose Drug: GSK618334 PET subjects PET subjects
Experimental: GSK618334 Medium Dose GSK618334 medium dose arm	Drug: GSK618334 PET subjects PET subjects Drug: GSK618334 Medium Dose Medium Dose
Experimental: GSK618334 High Dose GSK618334 High Dose Arm	Drug: GSK618334 PET subjects PET subjects Drug: GSK618334 High Dose GSK618334 High Dose
Experimental: GSK618334 Placebo Placebo for all 3 dose levels	Drug: GSK618334 Low Dose GSK618334 low dose Drug: GSK618334 Medium Dose Medium Dose Drug: GSK618334 High Dose GSK618334 High Dose

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01036061

Locations

United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7EW

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01036061 History of Changes
Other Study ID Numbers:	108414
Study First Received:	December 17, 2009
Last Updated:	August 23, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

compulsive discorders
addiction

Additional relevant MeSH terms:

Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013