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GSK2018682 CD2; GSK2018682 CD3 non-micronised; GSK2018682 CD3 micronised; GSK2018682 CD3 non-micronised in

Phase 1

Multiple Sclerosis, Relapsing-Remitting | Small molecule | Neurology |GSK plc|Last Updated: Jul 7, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

GSK2018682 CD2; GSK2018682 CD3 non-micronised; GSK2018682 CD3 micronised; GSK2018682 CD3 non-micronised in · 1 trial · 1 indication

Phase 1 1
NCT01466322A Study to Assess the Relative Bioavailability of Different Formulations of GSK2018682, a Sphingosine-1-phosphate Receptor Subtype 1 Agonist, in Healthy Volunteers.Multiple Sclerosis, Relapsing-Remitting
COMPLETED16 Analytics
PHASE1COMPLETED
A Study to Assess the Relative Bioavailability of Different Formulations of GSK2018682, a Sphingosine-1-phosphate Receptor Subtype 1 Agonist, in Healthy Volunteers.
Multiple Sclerosis, Relapsing-Remitting
NCT0146632216
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Study Endpoints

Primary Endpoints

To assess the pharmacokinetics of different oral formulations of GSK2018682 in healthy volunteers
PK sampling at dosing and at 1, 2, 3, 4, 6, 8, 10, 16, 24, 36, 48, 72, 96, 120, and 144 hr post-dose

-Peak blood concentration (Cmax); -Time of peak blood concentration (tmax); - Area under the blood concentration-time curve up to the last quantifiable time point (AUC(0-t)) and extrapolated to infinite time (AUC (0-∞)); -Terminal half-life (T½ ); -Apparent oral clearance (CL/F)

Secondary Endpoints

To investigate the effect of food on the pharmacokinetic parameters of the CD3 tablet formulation of GSK2018682
High fat breakfast to be provided within 30 mins prior to dosing
Evaluate the effect of different oral formulations of GSK2018682 on lymphocytes in healthy volunteers
Sampling for absolute lymphocyte count at dosing and at 6 and 24 hr post-dose.
To investigate the safety and tolerability of different oral formulations of GSK2018682 in healthy volunteers (males and females of non childbearing potential)
AE review: from dosing to follow-up; safety lab parameters: at 48 hr post-dose; Telemetry ECG: dosing to 6 hr post-dose; vital signs: pre-dose,1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 hr post-dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Oral formulations of GSK2018682EXPERIMENTALThree oral formulations of GSK2018682. A: CD2 Capsule; B: CD3 non-micronised Tablet; C: CD3 micronised Tablet; D: CD3 non-micronised Tablet in fed state

Interventions

NameTypeDescription
GSK2018682 CD2 Capsule; GSK2018682 CD3 non-micronised Tablet; GSK2018682 CD3 micronised Tablet; GSK2018682 CD3 non-micronised Tablet in fed stateDRUGFour single dosing sessions where each regimen A,B C or D will be administered orally in a randomised, cross-over manner. At each dosing session, pharmacokinetic sampling time-points will be the same.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Healthy as determined by a responsible and experienced physician, based on a medical evaluation in...

Countries:Australia
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