Brain Uptake of GSK1034702: a Positron Emission Tomography (PET) Scan Study
An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [Carbonyl-11C] GSK1034702 in Healthy Subjects
1 other identifier
interventional
4
1 country
2
Brief Summary
GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia. This study will be done in healthy men to investigate how much of the study drug gets into the brain. This will be done using Positron Emission Tomography (PET).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2009
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedStudy Start
First participant enrolled
July 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2009
CompletedJune 27, 2017
June 1, 2017
1 month
June 25, 2009
June 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Volume of distribution of [11C]GSK1034702 at tracer and pharmacological doses.
Scanning day
Secondary Outcomes (3)
The kinetic rate constants at tracer and pharmacological doses.
Scanning day
GSK1034702 PK parameters: Cmax; tmax; AUC(0-t).
Scanning day
Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations.
2 weeks
Study Arms (1)
GSK1034702
EXPERIMENTALSingle oral 5 mg dose in liquid formulation
Interventions
Eligibility Criteria
You may qualify if:
- Generally healthy.
- Male between 35 and 55 years of age.
- Willing to use appropriate contraception method.
- Weight more than 50 kg.
- BMI within the range 19 - 29 kg/m2.
- Adequate blood supply to the hand.
You may not qualify if:
- Abuse of drugs or alcohol.
- Smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months.
- ECG abnormality (personal or family history).
- Psychiatric disorder.
- Asthma or a history of asthma.
- Medical illness.
- Worked as a welder, metal worker or machinist.
- Suffers from claustrophobia or would be unable to lie still in a PET or MRI scanner for 1-2 hours.
- Has a cardiac pacemaker or other electrical device or ferromagnetic metal foreign bodies.
- Neurological disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
London, NW10 7EW, United Kingdom
GSK Investigational Site
London, W12 ONN, United Kingdom
Related Publications (1)
Ridler K, Cunningham V, Huiban M, Martarello L, Pampols-Maso S, Passchier J, Gunn RN, Searle G, Abi-Dargham A, Slifstein M, Watson J, Laruelle M, Rabiner EA. An evaluation of the brain distribution of [(11)C]GSK1034702, a muscarinic-1 (M 1) positive allosteric modulator in the living human brain using positron emission tomography. EJNMMI Res. 2014 Dec;4(1):66. doi: 10.1186/s13550-014-0066-y. Epub 2014 Dec 5.
PMID: 26116126DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2009
First Posted
July 13, 2009
Study Start
July 15, 2009
Primary Completion
August 28, 2009
Study Completion
August 28, 2009
Last Updated
June 27, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.