Last updated: 11/07/2018 03:04:12

Brain uptake of GSK1034702: a Positron Emission Tomography (PET) scan study

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GSK study ID
110771
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Clinicaltrials.gov ID
NCT00937846
EudraCT ID
2008-007450-35
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: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy subjects
Trial description: 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).
Primary purpose:
Supportive Care
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Volume of distribution of [11C]GSK1034702 at tracer and pharmacological doses.

Timeframe: Scanning day

Secondary outcomes:

The kinetic rate constants at tracer and pharmacological doses.

Timeframe: Scanning day

GSK1034702 PK parameters: Cmax; tmax; AUC(0-t).

Timeframe: 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.

Timeframe: 2 weeks

Interventions:
Drug: GSK1034702
Enrollment:
4
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Khanum Ridler, Vincent Cunningham, Mickael Huiban, Laurent Martarello, Sabina Pampols-Maso, Jan Passchier, Roger N. Gunn, Graham Searle, Anissa Abi-Dargham, Mark Slifstein, Jeanette Watson, Marc Laruelle, and Eugenii A. Rabiner. An evaluation of the brain distribution of [11C]GSK1034702, a Muscarinic-1 (M1) positive allosteric modulator in the living human brain using positron emission tomography. EJNMMI Res. 2014;4(66):
Medical condition
Cognitive Disorders
Product
GSK1034702
Collaborators
Not applicable
Study date(s)
July 2009 to August 2009
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
35 - 55 years
Accepts healthy volunteers
Yes
  • Generally healthy.
  • Male between 35 and 55 years of age.
  • Abuse of drugs or alcohol.
  • Smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months.
Inclusion and exclusion criteria
Inclusion criteria:
  • 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.
Exclusion criteria:
  • 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

Trial location(s)

Location
Status
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Location
GSK Investigational Site
London, United Kingdom, NW10 7EW
Status
Recruiting
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Location
GSK Investigational Site
London, London, United Kingdom, W12 ONN
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
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
2009-28-08

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 110771 can be found on the GSK Clinical Study Register.
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