NSB101909: First Study in Humans With GSK206136

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT01059578

Collaborator

(none)

Enrollment

Location

Arms

6.9

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder and Anxiety Disorders	Drug: GSK206136 Drug: PLACEBO Radiation: PET	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 23, 2006

Actual Primary Completion Date :

Dec 18, 2006

Actual Study Completion Date :

Dec 18, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active GSK206136 once daily	Drug: GSK206136 GSK206136 2mg, 10mg, 50mg, 100mg capsule Radiation: 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
Placebo Comparator: Placebo Placebo once daily	Drug: PLACEBO Placebo to match 206136 2mg, 10mg, 50mg, 100mg capsule

Arm

Intervention/Treatment

Experimental: Active

GSK206136 once daily

Drug: GSK206136

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

Radiation: 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

Placebo Comparator: Placebo

Placebo once daily

Drug: PLACEBO

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

Outcome Measures

Primary Outcome Measures

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

Brain receptor occupancy [2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.