First Study in Humans With GSK206136 (NSB101909)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Depressive Disorder and Anxiety Disorders

Treatments: Drug: GSK206136; Drug: PLACEBO; Radiation: PET

Study type: Interventional

Funder types: Industry

Identifiers

NCT01059578

101909

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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33 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

GSK206136 once daily

Treatment:

Drug: GSK206136

Radiation: PET

Placebo

Placebo Comparator group

Description:

Placebo once daily

Treatment:

Drug: PLACEBO