Back to resultsFirst Study in Humans With GSK206136 (NSB101909)
Primary Purpose
Depressive Disorder and Anxiety Disorders
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
GSK206136
PLACEBO
PET
Sponsored by
About this trial
This is an interventional basic science trial for Depressive Disorder and Anxiety Disorders focused on measuring Nk1 Antagonist and SSRI, Safety, First Time in Humans, Healthy Subjects
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
GSK206136 once daily
Placebo once daily
Outcomes
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
Secondary Outcome Measures
Brain receptor occupancy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01059578
Brief Title
First Study in Humans With GSK206136
Acronym
NSB101909
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 23, 2006 (Actual)
Primary Completion Date
December 18, 2006 (Actual)
Study Completion Date
December 18, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder and Anxiety Disorders
Keywords
Nk1 Antagonist and SSRI, Safety, First Time in Humans, Healthy Subjects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
GSK206136 once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily
Intervention Type
Drug
Intervention Name(s)
GSK206136
Intervention Description
GSK206136 2mg, 10mg, 50mg, 100mg capsule
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
Placebo to match 206136 2mg, 10mg, 50mg, 100mg capsule
Intervention Type
Radiation
Intervention Name(s)
PET
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Brain receptor occupancy
Time Frame
2 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE1 1YR
Country
United Kingdom
12. IPD Sharing Statement
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First Study in Humans With GSK206136
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