Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2018682 CD2; GSK2018682 CD3 non-micronised; GSK2018682 CD3 micronised; GSK2018682 CD3 non-micronised · 1 trial · 1 indication
-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)
| Arm | Type | Description |
|---|---|---|
| Oral formulations of GSK2018682 | EXPERIMENTAL | Three oral formulations of GSK2018682. A: CD2 Capsule; B: CD3 non-micronised Tablet; C: CD3 micronised Tablet; D: CD3 non-micronised Tablet in fed state |
| Name | Type | Description |
|---|---|---|
| GSK2018682 CD2 Capsule; GSK2018682 CD3 non-micronised Tablet; GSK2018682 CD3 micronised Tablet; GSK2018682 CD3 non-micronised Tablet in fed state | DRUG | Four 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. |
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...
GSK2018682 is being developed for relapsing-remitting multiple sclerosis, a form of MS marked by episodes of new or worsening neurological symptoms. It is an investigational small molecule and has not been approved for any indication. Development remains at the Phase 1 stage, so its use in patients is still under study.
GSK2018682 is a sphingosine-1-phosphate receptor subtype 1 agonist. It targets the S1P1 receptor, a G protein-coupled receptor that regulates lymphocyte trafficking. By acting on this receptor, the drug is designed to modulate immune cell movement, which is relevant to the inflammatory process in relapsing-remitting multiple sclerosis.
GSK2018682 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the clinical program for the asset, including the Phase 1 bioavailability study conducted in Australia. GSK plc is the sole developer named for this investigational compound.
GSK2018682 is in Phase 1 development. It is an investigational drug and has not been approved by the FDA or any other regulator. The only recorded trial is a completed Phase 1 study, and no active trials are currently listed for the asset.
GSK2018682 has been studied in one completed Phase 1 trial, NCT01466322. That study assessed the relative bioavailability of different formulations of GSK2018682 in 16 healthy volunteers in Australia. It was randomized but uncontrolled and not double-blind, and it has completed.
Yes. GSK2018682 CD2 and GSK2018682 CD3 are formulation names for the same investigational compound, GSK2018682. CD2 refers to a capsule form, while CD3 refers to tablet forms described as non-micronised or micronised, including a non-micronised tablet tested in the fed state.