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First Study in Humans With GSK424887

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ClinicalTrials.gov Identifier: NCT01059591
Recruitment Status : Completed
First Posted : February 1, 2010
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is the first study in Humans with GSK424887 to evaluate what effects, good or bad, the drug has on human health (safety and tolerability) and the amount of drug which gets into the bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to investigate the penetration of the drug in the human brain by using PET (Positron Emission Tomography) imaging technology

Condition or disease Intervention/treatment Phase
Depressive Disorder and Anxiety Disorders Drug: GSK424887 Drug: Placebo Radiation: PET Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Single Blind, Randomised, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK424887 in Healthy Male Subjects and an Open Label Positron Emission Tomography Study to Evaluate the Serotonin Transporter and Neurokinin- Receceptor Occupancy
Actual Study Start Date : May 25, 2006
Primary Completion Date : January 25, 2007
Study Completion Date : January 25, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Active
GSK424887 once daily
Drug: GSK424887
GSK424887 2mg, 10mg, 50mg, 100mg capsule
Radiation: PET
Each subject will undergo 3 PET scans : one at Baseline and the others following dosing with GSK424887 at approximately 2h post-dose and aproximately 24 hours post-dose
Placebo Comparator: Placebo
Placebo once daily
Drug: Placebo
Placebo to match GSK424887 2mg, 10mg,50mg, 100mg capsule


Outcome Measures

Primary Outcome Measures :
  1. Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) , tmax [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Brain receptor occupancy [ Time Frame: 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males aged 18-45 years, limited to 25-40 years for PET section

Exclusion Criteria:

  • The subject has a positive: drug/alcohol, Hepatitis, HIV screen
  • The subject has a history of psychiatric illness suicidal attempts or behaviour.
  • Abuse of alcohol.
  • Clinically significant laboratory, ECG abnormality;
  • The subject has recently received an investigational.
  • Use of prescription or non-prescription drugs,
  • History or presence of allergy to the study drug or drugs of this class,.
  • Donation of more than 500 mL blood within the 90 days before dosing.
  • An unwillingness of male subjects to comply with contraceptive requirements
  • Average daily caffeine intake exceeding Protocol requirements.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059591


Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01059591     History of Changes
Other Study ID Numbers: 105011
First Posted: February 1, 2010    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
NK1 antagonist and SSRI
Healthy subjects
Safety
First time in Human

Additional relevant MeSH terms:
Depressive Disorder
Depression
Anxiety Disorders
Mood Disorders
Mental Disorders
Behavioral Symptoms