First Study in Humans With GSK424887

August 10, 2017 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 1YR
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Brain receptor occupancy
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2006

Primary Completion (Actual)

January 25, 2007

Study Completion (Actual)

January 25, 2007

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

January 29, 2010

First Posted (Estimate)

February 1, 2010

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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