First Study in Humans With GSK206136 | NCT01059578

Studies
First Study in Humans With GSK206136

NCT01059578

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Aug 10, 2017Actual

Enrollment

33Actual

Phase

Phase 1

Conditions

Depressive Disorder and Anxiety Disorders

Interventions

GSK206136
PLACEBO
PET

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2006Actual

Primary Completion Date

Dec 18, 2006Actual

Completion Date

Dec 18, 2006Actual

First Submitted Date

Jan 28, 2010

First Submission Date that Met QC Criteria

Jan 28, 2010

First Posted Date

Feb 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2017

Last Update Posted Date

Aug 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	GSK206136 once daily	Drug: GSK206136 Radiation: PET
Placebo	Placebo Comparator	Placebo once daily	Drug: PLACEBO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSK206136	Drug	GSK206136 2mg, 10mg, 50mg, 100mg capsule	Active
PLACEBO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); pharmacokinetics parameters: AUC, Cmax, t1/2		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Brain receptor occupancy		2 weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		London		SE1 1YR	United Kingdom

References Module

Citations

Not provided

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D003866	Depressive Disorder
D001008	Anxiety Disorders