Emotional Processing in Healthy Volunteers in the Presence of an Investigational Anxiolytic

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01424384
First received: February 12, 2010
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

This will be a phase I, single centre, randomised, double blind, double-dummy, placebo controlled, parallel group single-dose study in healthy volunteers. The purpose of this study is to assess the effect of a single-dose administration of GSK424887, a potent, selective competitive antagonist of the human Neurokinin 1 (NK1) receptor and a potent inhibitor of the human serotonin transporter (SERT), at the maximum dosage of 100 mg versus placebo and versus citalopram (20 mg) on emotional processing in healthy male volunteers. Pharmacokinetics and safety following oral administration of GSK424887 will be also evaluated. An Emotional Test Battery (ETB) previously used to characterise the effects of antidepressants on positive and negative emotion processing in Healthy Volunteers and patients will be used. We hypothesise that GSK424887 will modulate emotional information processing acutely. We anticipate that these effects may be manifest at sub-effective levels of NK1 and SERT receptor occupancy, thus providing pharmacodynamic evidence of the synergistic interaction of the two mechanisms in humans.


Condition Intervention Phase
Depressive Disorder and Anxiety Disorders
Drug: Citalopram
Drug: GSK424887
Drug: Plactebo To Match
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Emotional Processing in Healthy Male Volunteers Treated With GSK424887. A Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Multiple emotional and psychometric battery of tests [ Time Frame: < 1 day ] [ Designated as safety issue: No ]
  • Adverse Events, laboratory values, vital signs, ECGs [ Time Frame: < 1 day ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: September 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Citalopram
Marketed comparitor
Drug: Citalopram
Neurophysiological testing.
Experimental: Investigational Medicinal Product
GSK424887
Drug: GSK424887
Neurophysiological testing
Placebo Comparator: Placebo To Match Treatment
Placebo control
Drug: Plactebo To Match
Neurophysiological testing

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males with no neurological, or history of psychiatric illness
  2. Aged between 18 and 45 years
  3. Agree to use contraception
  4. BMI range of 18 to 33 kg/m²
  5. Fluent English speakers
  6. Non smoker or light smoker

Exclusion Criteria:

  1. Positive pre-study drug/alcohol screen or regular alcohol consumption
  2. Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  3. On prescription or non prescription drug
  4. Exposure to more than four new chemical entities within 12 months prior to the first dosing day
  5. Consumption of large amounts of caffeinated drinks
  6. Significant hearing impairment
  7. Previous experience of the emotional test battery experimental procedures
  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: NCT01424384

Locations
United Kingdom
GSK Investigational Site
Oxford, United Kingdom, OX3 7JX
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01424384     History of Changes
Other Study ID Numbers: 105012
Study First Received: February 12, 2010
Last Updated: May 10, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
healthy volunteers
Anxiety Disorder
neuropsychological tests

Additional relevant MeSH terms:
Anxiety Disorders
Depressive Disorder
Depression
Mental Disorders
Mood Disorders
Behavioral Symptoms
Citalopram
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on July 26, 2014