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TerminatedPhase 1

GSK2647544 RD, DDI in Healthy Young and Elderly Volunteers

Single-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Doses of GSK2647544 and Its Potential Pharmacokinetic Interaction With Simvastatin in Healthy Volunteers

Lead sponsor

GlaxoSmithKline

Asset

GSK2647544

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥18

Primary endpoints

•Safety and tolerability of GSK2647544•Peak plasma concentration (Cmax) of GSK2647544•Time of peak plasma concentration (tmax) of GSK2647544

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID200592

NCT IDNCT01978327

Timeline

Milestones

Study first posted2013-11-07estimated

Study start2013-11-22actual

Primary completion2014-03-03actual

Study completion2014-03-03actual

Last update posted2017-06-08actual

Assets

Drug assets

GSK2647544

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Males and females who are 18 to 64 years of age inclusive, defined as young subjects in this study, are eligible for Cohorts 1-3 only

•Males and females who are ≥65 years of age, defined as elderly subjects in this study, are eligible for Cohort 4 only

•Healthy as determined by a responsible and experienced physician

•A female subject is eligible to participate if she is of non-childbearing potential

•Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods

•Body weight > 50 kg (110 pounds) and body mass index (BMI) between 19 and 32

•Aspartate aminotransferase (AST), Alanine transaminase (ALT), alkaline phosphatase and bilirubin <= 1.5xUpper Limit of Normal (ULN)

•Average of triplicate QTcB values and average of triplicate QTcF values must both < 450 msec

•Capable of giving written informed consent

Exclusion criteria

•Subjects with Lp-PLA2 activity <=20 nanomole/minute/milliliter (mL)(for subjects with 2 known birth parents of at least 50% Japanese, Chinese, or Korean ancestry)

•History of asthma, anaphylaxis or anaphalactoid reactions, severe allergic responses

•History of hypercoagulable state or history of thrombosis

•History of biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology

•Positive Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C at screening

•History of regular use of tobacco or nicotine-containing products within 6 months of the study

•Unable to abstain from alcohol or caffeine or xanthine-containing products for 24 h prior to the start of dosing

•Unable to refrain from use of prescription or non-prescription drugs and vitamins within 7 days or 5 half-lives (whichever is longer) prior to administration of study

•Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening (Note: This applies to healthy young subjects screened for Cohorts 1-3 only. Healthy elderly subjects for cohort 4 who are social smokers must give up smoking for the period that they will be on the unit)

•positive pre-study drug/alcohol screen

•Unable to refrain from consumption of Seville oranges, grapefruit or grapefruit juice within 7 days prior to the first dose of study medication until the follow-up visit

•Subjects who have taken statins, medicines that are contraindications of statins, know potent inhibitiors or inducers of CYP3A4 in the 4 weeks or 5 half-lives (whichever is longer) prior to screening and are not able to discontinue use throughout participation in the clinical trial

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

12 endpoints

Primary/protocol endpoint

Safety and tolerability of GSK2647544 as assessed by number of subjects with adverse events (AE)s

Time frame:up to 19 days in each dosing session

event count, event

Primary/protocol endpoint

Safety and tolerability of GSK2647544 as assessed by change from Baseline in laboratory values

Time frame:up to 15 days in each dosing session

change from baseline, event

Primary/protocol endpoint

Safety and tolerability of GSK2647544 as assessed by change from Baseline in ECG readings

Time frame:up to 19 days in each dosing session

change from baseline, event

Primary/protocol endpoint

Safety and tolerability of GSK2647544 as assessed by change from Baseline in Telemetry ECG parameters

Time frame:2 days in Cohorts 1, 2 and 4; 3 days in Cohort 4

change from baseline, event

Primary/protocol endpoint

Safety and tolerability of GSK2647544 as assessed by change from Baseline in vital signs

Time frame:up to 19 days in each dosing session

change from baseline, event

Primary/protocol endpoint

Safety and tolerability of GSK2647544 as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)

Time frame:4 days in Cohorts 1 and 2; 8 days in Cohorts 3 and 4

descriptive

Primary/protocol endpoint

Peak plasma concentration (Cmax) of GSK2647544

Time frame:up to 17 days in GSK2647544 dosing sessions

concentration, descriptive

Primary/protocol endpoint

Time of peak plasma concentration (tmax) of GSK2647544

Time frame:up to 17 days in GSK2647544 dosing sessions

concentration, descriptive

Primary/protocol endpoint

Area under the time concentration curve (AUC) of GSK2647544

Time frame:up to 17 days in GSK2647544 dosing sessions

concentration, descriptive

Primary/protocol endpoint

Terminal half-life (t½ ) of GSK2647544

Time frame:up to 17 days in GSK2647544 dosing sessions

concentration, descriptive

Primary/protocol endpoint

Time of peak plasma concentration (tmax) of simvastatin

Time frame:4 days in Cohorts 1 and 3

concentration, descriptive

Primary/protocol endpoint

Area under the time concentration curve (AUC) of simvastatin

Time frame:4 days in Cohorts 1 and 3

concentration, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Predose plasma lipoprotein-associated phospholipase A2 (Lp-PLA2) activity and postdose Lp-PLA2 activity

Time frame:up to 18 days in GSK2647544 dosing sessions

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.