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GSK2981710

Phase 1

Alzheimer's Disease | Small molecule | Neurology |GSK plc|Last Updated: May 9, 2017

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment116

FDA Designations

No designations recorded

Clinical trial landscape

GSK2981710 · 1 trial · 1 indication

Phase 1 1
NCT01702480Effects of Triglycerides on Age-Related Cognitive Function Decline in Older SubjectsAlzheimer's Disease
COMPLETED116 Analytics
PHASE1COMPLETED
Effects of Triglycerides on Age-Related Cognitive Function Decline in Older Subjects
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Plasma BHB elevation time course of GSK2981710
Baseline (Day 0 pre dose) and Day 1 post dose (per 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6, 6.5, 7, 7.5 and 8 hrs) of each of the 4 treatment periods.

To select the dose of GSK2981710 that achieves the best PK profile, the duration of maximum elevation of beta-hydroxybutrate (BHB) will be measured.

Part 1: Area under the time concentration curve (AUC) of GSK2981710
Baseline (Day 0 pre dose) and Day 1 post dose (per 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6, 6.5, 7, 7.5 and 8 hrs) of each of the 4 treatment periods.

To select the dose of GSK2981710 that achieves the best PK profile the AUC of GSK2981710 will be measured.

Part 1: Maximum concentration (Cmax) of GSK2981710
Baseline (Day 0 pre dose) and Day 1 post dose (per 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6, 6.5, 7, 7.5 and 8 hrs) of each of the 4 treatment periods.

To select the dose of GSK2981710 that achieves the best PK profile the Cmax of GSK2981710 will be measured.

Part 2: Change from Baseline in performance on CANTAB Paired Associates Learning task
Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.

To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used. This test assesses visual memory and new learning

Part 2: Change from Baseline in performance on CANTAB Verbal Recognition Memory task
Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.

To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test assesses the participant's ability to recall as many of the words as possible immediately following the presentation of list of words.

Part 2: Change from Baseline in performance on CANTAB Spatial Working Memory (SWM) task
Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.

To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test assesses the participant's ability to retain spatial information and to manipulate remembered items in working memory.

Part 2: Change from Baseline in performance on CANTAB Rapid Visual Processing task
Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.

To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test assesses continuous performance and visual sustained attention.

Part 2: Change from Baseline in performance on CANTAB Reaction Time task
Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.

To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test measures of attention, and combines simple reaction time and choice reaction time elements

Part 2: Change from Baseline in performance on Source Memory Task
Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.

This test measures the participant's ability to recognize objects previously presented on a computer screen, and more importantly, to recall the spatial location of those objects.

Secondary Endpoints

Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by number of subjects with adverse events (AE)s
Part 1: 3 weeks; Part 2: 8 weeks
Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by change from Baseline in ECG readings
Part 1: Baseline and 3 to 5 days post last dose in each of the 4 treatment periods.
Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by change from Baseline in laboratory values
Part 1: Baseline and 3 to 5 days post last dose in each of the 4 treatment periods.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: GSK2981710 10 gram (g)EXPERIMENTALEight subjects will receive single dose of GSK2981710 in the form of 10 g medium-chain triglycerides (MCT) powder daily for 14 days.
Part 1: GSK2981710 20 gEXPERIMENTALEight subjects will receive single dose of GSK2981710 in the form of 20 g MCT powder daily for 14 days.
Part 1: GSK2981710 30 gEXPERIMENTALEight subjects will receive single dose of GSK2981710 in the form of 30 g MCT powder daily for 14 days.
Part 1: GSK2981710 40 gEXPERIMENTALEight subjects will receive single dose of GSK2981710 in the form of 40 g MCT powder daily for 14 days.
Part 1: PlaceboPLACEBO_COMPARATOREight subjects will receive single dose of matching placebo daily for 14 days.
Part 2: GSK2981710 (dose to be decided from Part 1)EXPERIMENTALThe subjects will receive single dose of GSK2981710 in the form of MCT powder (dose to be decided from Part 1) daily for 14 days.
Part 2: PlaceboPLACEBO_COMPARATORThe subjects will receive single dose of matching placebo daily for 14 days..

Interventions

NameTypeDescription
GSK2981710DRUGWill be available as 10 g medium-chain triglycerides (MCT) powder sachet that will be mixed with 125 - 250 milliliters (ml) water in a shaker and taken within 15 minutes of completion of breakfast
PlaceboDRUGWill be available as matching powder that will be mixed with 125 - 250 milliliters (ml) water in a shaker and taken within 15 minutes of completion of breakfast
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Eligibility Criteria

Age Range55 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female individuals between the ages of 55 years and 80 years inclusive. * A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined ...

Countries:United Kingdom
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Frequently asked questions about GSK2981710

What is GSK2981710 used for?

GSK2981710 is an investigational small molecule being developed for Alzheimer's Disease. It is in Phase 1 clinical development, meaning it is still being studied in early-stage trials and has not been approved for use.

Who makes GSK2981710?

GSK2981710 is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK.

What phase is GSK2981710 in?

GSK2981710 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials.

What clinical trials is GSK2981710 in?

GSK2981710 has been studied in one completed Phase 1 clinical trial, identified as NCT01702480. This trial, titled 'Effects of Triglycerides on Age-Related Cognitive Function Decline in Older Subjects,' enrolled 116 participants in the United Kingdom.

Is GSK2981710 FDA approved?

GSK2981710 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Alzheimer's Disease, and it has not yet been authorized for commercial use.