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First Study in Humans With GSK206136 (NSB101909)

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ClinicalTrials.gov Identifier: NCT01059578
Recruitment Status : Completed
First Posted : February 1, 2010
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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 Type : Interventional  (Clinical Trial)
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 : December 18, 2006
Actual Study Completion Date : December 18, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  1. 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 :
  1. Brain receptor occupancy [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059578


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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01059578     History of Changes
Other Study ID Numbers: 101909
First Posted: February 1, 2010    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

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

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