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First Study in Humans With GSK206136 (NSB101909)

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: January 28, 2010
Last updated: August 9, 2017
Last verified: August 2017
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
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

Resource links provided by NLM:

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 ]

Secondary Outcome Measures:
  • Brain receptor occupancy [ Time Frame: 2 weeks ]

Enrollment: 33
Actual Study Start Date: May 23, 2006
Study Completion Date: December 18, 2006
Primary Completion Date: December 18, 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
Placebo to match 206136 2mg, 10mg, 50mg, 100mg capsule


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01059578

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

Additional Information:
Responsible Party: GlaxoSmithKline Identifier: NCT01059578     History of Changes
Other Study ID Numbers: 101909
Study First Received: January 28, 2010
Last Updated: August 9, 2017

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

Additional relevant MeSH terms:
Depressive Disorder
Anxiety Disorders
Mood Disorders
Mental Disorders
Behavioral Symptoms processed this record on September 21, 2017