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First Study in Humans With GSK206136 (NSB101909)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01059578
First received: January 28, 2010
Last updated: November 8, 2012
Last verified: November 2012
History of Changes

January 28, 2010
November 8, 2012
May 2006
December 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01059578 on ClinicalTrials.gov Archive Site
Brain receptor occupancy [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
First Study in Humans With GSK206136
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

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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Depressive Disorder and Anxiety Disorders
  • Drug: GSK206136
    GSK206136 2mg, 10mg, 50mg, 100mg capsule
  • Drug: PLACEBO
    Placebo to match 206136 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
  • Experimental: Active
    GSK206136 once daily
    Interventions:
    • Drug: GSK206136
    • Radiation: PET
  • Placebo Comparator: Placebo
    Placebo once daily
    Intervention: Drug: PLACEBO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
December 2006
December 2006   (final data collection date for primary outcome measure)

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.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01059578
101909
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP