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GSK618334 Repeat Dose Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01036061
First received: December 17, 2009
Last updated: June 21, 2017
Last verified: June 2017
  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 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
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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.

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 ]
  • To assess blood concentrations of GSK618334 after repeated oral doses. [ Time Frame: First dose to 72 hours post last dose ]

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 ]
  • 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 ]

Enrollment: 46
Actual Study Start Date: September 28, 2009
Study Completion Date: February 17, 2010
Primary Completion Date: February 17, 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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 108414
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 108414
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 108414
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 108414
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 108414
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 108414
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01036061     History of Changes
Other Study ID Numbers: 108414
Study First Received: December 17, 2009
Last Updated: June 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by GlaxoSmithKline:
compulsive discorders
addiction

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 23, 2017