First Study in Humans With GSK206136
NSB101909
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
1 other identifier
interventional
33
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2006
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2006
CompletedFirst Submitted
Initial submission to the registry
January 28, 2010
CompletedFirst Posted
Study publicly available on registry
February 1, 2010
CompletedAugust 10, 2017
August 1, 2017
7 months
January 28, 2010
August 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Brain receptor occupancy
2 weeks
Study Arms (2)
Active
EXPERIMENTALGSK206136 once daily
Placebo
PLACEBO COMPARATORPlacebo once daily
Interventions
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 Criteria
You may qualify if:
- Healthy males aged 18-45 years, limited to 25-40 years of age for PET section
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
London, SE1 1YR, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2010
First Posted
February 1, 2010
Study Start
May 23, 2006
Primary Completion
December 18, 2006
Study Completion
December 18, 2006
Last Updated
August 10, 2017
Record last verified: 2017-08