Last updated: 11/02/2018 23:42:53

First study in humans with GSK206136NSB101909

GSK study ID
101909
See study documents
Clinicaltrials.gov ID
NCT01059578
EudraCT ID
2006-001600-36
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); pharmacokinetics parameters: AUC, Cmax, t1/2

Timeframe: 12 weeks

Secondary outcomes:

Brain receptor occupancy

Timeframe: 2 weeks

Interventions:
Drug: GSK206136
Drug: PLACEBO
Radiation: PET
Enrollment:
33
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Depressive Disorder and Anxiety Disorders
Product
GSK206136
Collaborators
Not applicable
Study date(s)
May 2006 to December 2006
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
  • Healthy males aged 18-45 years, limited to 25-40 years of age for PET section
  • The subject has a positive: drug/alcohol, Hepatitis, HIV screen..
  • The subject has a history of psychiatric illness suicidal attempts or behaviour.
Inclusion and exclusion 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
London, United Kingdom, SE1 1YR
Status
Terminated/Withdrawn
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Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-18-12

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study 101909 can be found on the GSK Clinical Study Register.
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