A Single Blind, Randomised, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK206136 in Healthy Male Subjects and an Open Label Positron Emission Tomography Study to Evaluate the Serotonin Transporter and Neurokinin-1 Receptor Occupancy

GlaxoSmithKline1 site in 1 country33 target enrollmentMay 23, 2006

ConditionsDepressive Disorder and Anxiety Disorders

InterventionsPLACEBO GSK206136 PET

DrugsGSK206136 PLACEBO

Overview

Phase: Phase 1
Intervention: PLACEBO
Conditions: Depressive Disorder and Anxiety Disorders
Sponsor: GlaxoSmithKline
Enrollment: 33
Locations: 1
Primary Endpoint: Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); pharmacokinetics parameters: AUC, Cmax, t1/2
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is the first study in humans with GSK206136 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

Registry

clinicaltrials.gov

Start Date

May 23, 2006

End Date

December 18, 2006

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy males aged 18-45 years, limited to 25-40 years of age 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.

Arms & Interventions

Placebo

Placebo once daily

Intervention: PLACEBO

Active

GSK206136 once daily

Intervention: GSK206136

Active

GSK206136 once daily

Intervention: PET

Outcomes

Primary Outcomes

Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); pharmacokinetics parameters: AUC, Cmax, t1/2

Time Frame: 12 weeks