First Study in Humans With GSK424887

Depressive Disorder and Anxiety Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059591
• Other study ID #: 105011
• Status: Completed
• Phase: Phase 1
• First received: January 28, 2010
• Last updated: August 10, 2017
• Start date: May 25, 2006
• Est. completion date: January 25, 2007

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 25, 2007
• Est. primary completion date: January 25, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder and Anxiety Disorders

Intervention

Drug:
• GSK424887
GSK424887 2mg, 10mg, 50mg, 100mg capsule
• Placebo
Placebo to match 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

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 weeks
Secondary	Brain receptor occupancy		2 weeks

External Links

•   Results for study 105011 can be found on the GSK Clinical Study Register.