A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward

NCT00605241 | Completed Phase 1

• 1 other identifier: DAN106593
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

GSK598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will asses the effects of a single dose of GSK598809 in modulating nicotine reward in 2 cohorts of otherwise healthy male volunteers who smoke. Each cohort of subjects will receive a single dose of placebo or GSK598809 in two dosing sessions binded crossover fashine. There will be a washout period of at least seven days between each session.

Conditions

Substance Dependence

Keywords

pharmacodynamics,; pharmacokinetics,; tolerability,; Safety,; single dose,; placebo,; Nicotine reward; GSK598809

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  through 24 hours

Secondary Outcomes (1)

• Stroop test

  through 10 hours

Study Arms (1)

GSK598809

OTHER

Drug

Drug: GSK598809

Interventions

GSK598809 DRUG

Drug

GSK598809

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male smokers aged 18-65 with a desire to quit smoking.
• Body weight greater than 50kg and BMI within range 19 - 29.9 kg/m2
• Healthy with no significant medical, psychiatric or laboratory evaluation abnormality.

You may not qualify if:

• Positive pre-study urine drug/breath alcohol screen: positive HIV 1/2, Hepatitis B or Hepatitis C test at screening.
• History of alcohol/drug abuse or dependence (other than nicotine) within 12 months of the study.
• History of psychiatric disorder or sensitivity to any of the study medications or components thereof or a history of drug or allergy that in the opinion of the physician responsible contraindicates their participation.
• History of cardiac or pulmonary disease/abnormalities.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Mugnaini M, Iavarone L, Cavallini P, Griffante C, Oliosi B, Savoia C, Beaver J, Rabiner EA, Micheli F, Heidbreder C, Andorn A, Merlo Pich E, Bani M. Occupancy of brain dopamine D3 receptors and drug craving: a translational approach. Neuropsychopharmacology. 2013 Jan;38(2):302-12. doi: 10.1038/npp.2012.171. Epub 2012 Sep 12.

  PMID: 22968817 BACKGROUND

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 DAN106593 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

GSK598809

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: January 31, 2008
• Study Start: February 25, 2008
• Primary Completion: March 20, 2009
• Study Completion: March 20, 2009
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)