First Study in Humans With GSK206136

Phase 1

Completed

• Conditions: Depressive Disorder and Anxiety Disorders
• Interventions: Drug: GSK206136; Drug: PLACEBO; Radiation: PET

• Registration Number: NCT01059578
• Lead Sponsor: GlaxoSmithKline

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-23
• Primary Completion: 2006-12-18
• Study Completion: 2006-12-18
• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-01-28
• Study First Posted: 2010-02-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active	GSK206136	GSK206136 once daily
Placebo	PLACEBO	Placebo once daily
Active	PET	GSK206136 once daily

Primary Outcome Measures

Name	Time	Method
Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); pharmacokinetics parameters: AUC, Cmax, t1/2	12 weeks

Secondary Outcome Measures

Name	Time	Method
Brain receptor occupancy	2 weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom