GSK618334 Repeat Dose Study

Substance Dependence Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01036061
• Other study ID #: 108414
• Status: Completed
• Phase: Phase 1
• First received: December 17, 2009
• Last updated: June 21, 2017
• Start date: September 28, 2009
• Est. completion date: February 17, 2010

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 17, 2010
• Est. primary completion date: February 17, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Dependence
• Substance-Related Disorders

Intervention

Drug:
• GSK618334 Low Dose
GSK618334 low dose
• GSK618334 PET subjects
PET subjects
• GSK618334 Medium Dose
Medium Dose
• GSK618334 High Dose
GSK618334 High Dose

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		First dose to follow-up
Primary	To assess blood concentrations of GSK618334 after repeated oral doses.		First dose to 72 hours post last dose
Secondary	To assess the effect of food on GSK618334 blood concentrations after a single dose.		First dose of the single dose session to 24 hours after dosing of the repeat dose session
Secondary	The dopamine type 3 receptor binding in the brain (by PET scan) of GSK618334 following the repeat dose session.		First dose to 24 hours after last dose

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 108414 can be found on the GSK Clinical Study Register.