GSK618334 Repeat Dose Study

NCT01036061 | Completed Phase 1

• 1 other identifier: 108414
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Dependence

Keywords

compulsive discorders; addiction

Outcome Measures

Primary Outcomes (2)

• 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

• To assess blood concentrations of GSK618334 after repeated oral doses.

  First dose to 72 hours post last dose

Secondary Outcomes (2)

• 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

• 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

Study Arms (4)

GSK618334 low Dose

EXPERIMENTAL

GSK618334 Low Dose

Drug: GSK618334 Low Dose; Drug: GSK618334 PET subjects

GSK618334 Medium Dose

EXPERIMENTAL

GSK618334 medium dose arm

Drug: GSK618334 PET subjects; Drug: GSK618334 Medium Dose

GSK618334 High Dose

EXPERIMENTAL

GSK618334 High Dose Arm

Drug: GSK618334 PET subjects; Drug: GSK618334 High Dose

GSK618334 Placebo

EXPERIMENTAL

Placebo for all 3 dose levels

Drug: GSK618334 Low Dose; Drug: GSK618334 Medium Dose; Drug: GSK618334 High Dose

Interventions

GSK618334 Low Dose DRUG

GSK618334 low dose

GSK618334 Placebo; GSK618334 low Dose

GSK618334 PET subjects DRUG

PET subjects

GSK618334 High Dose; GSK618334 Medium Dose; GSK618334 low Dose

GSK618334 Medium Dose DRUG

Medium Dose

GSK618334 Medium Dose; GSK618334 Placebo

GSK618334 High Dose DRUG

GSK618334 High Dose

GSK618334 High Dose; GSK618334 Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Significant suicidal risk.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, NW10 7EW, United Kingdom

Location

Related 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.

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: September 28, 2009
• Primary Completion: February 17, 2010
• Study Completion: February 17, 2010
• Last Updated: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)