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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
  Purpose

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 Intervention Phase
Depressive Disorder and Anxiety Disorders
 Drug: GSK206136
Drug: PLACEBO
Radiation: PET
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brain receptor occupancy [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: May 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059578

Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01059578     History of Changes
Other Study ID Numbers: 101909
Study First Received: January 28, 2010
Last Updated: November 8, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Nk1 Antagonist and SSRI
Safety
First Time in Humans
Healthy Subjects

Additional relevant MeSH terms:
Anxiety Disorders
Depressive Disorder
Depression
 Mental Disorders
Mood Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 19, 2013