First Study in Humans With GSK206136

GlaxoSmithKline33 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Depressive Disorder and Anxiety Disorders

Interventions

GSK206136DRUG

GSK206136 2mg, 10mg, 50mg, 100mg capsule

PLACEBODRUG

Placebo to match 206136 2mg, 10mg, 50mg, 100mg capsule

PETRADIATION

Each subject will undergo 3 PET Scans ; one at Baseline and the others following dosing with GSK206136 at approximately 2 hours post-dose and 24 hours post-dose

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

London, United Kingdom

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

Secondary Outcomes

Brain receptor occupancy

Time frame: 2 weeks

Data from ClinicalTrials.gov

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