Last updated: 11/02/2018 23:42:53
First study in humans with GSK206136NSB101909
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
Enrollment:
33
Primary completion date:
Not applicable
Observational study model:
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)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
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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