First Study in Humans With GSK206136

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-23

Study Completion Date

2006-12-18

Brief Summary

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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

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Detailed Description

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Conditions

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Depressive Disorder and Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active

GSK206136 once daily

Group Type EXPERIMENTAL

GSK206136

Intervention Type DRUG

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

PET

Intervention Type RADIATION

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

Placebo

Placebo once daily

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DRUG

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

Interventions

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GSK206136

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

Intervention Type DRUG

PLACEBO

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

Intervention Type DRUG

PET

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

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes