Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2018682 · 2 trials · 2 indications
Adverse event monitoring, Laboratory parameters (haematology, clinical chemistry, urinalysis), Ophthalmic examination
12-lead ECG, Telemetry ECG, Holter ECG, Vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, body temperature), Ambulatory blood pressure monitoring
FEV1 obtained via spirometry
Peak blood concentration, Time of peak blood concentration, Area under the blood concentration-time curve over the 24-hour dose interval and area under the blood concentration-time curve from time-zero extrapolated to infinite time, Accumulation ratio, Terminal half-life, Apparent oral clearance, Through concentration
GSK2018682 bile metabolites, GSK2018682 whole blood metabolites
% Change from baseline in absolute lymphocyte counts (ALC), % Change from baseline in subsets CD3+ \[CD4+ and CD8+\], CD19+, CD16+/CD56+ counts, % Change from baseline in further defined functional T cell subsets (naïve, central memory, effector memory and regulatory T cells)
PK/PD model with parameters of the models will be determined that best describe the relationship between blood concentrations of GSK2018682 and vital signs and ECG parameters
PK/PD model with parameters of the models will be determined that best describe the relationship between blood concentrations of GSK2018682 and reduction ALC and subset counts CD3+ \[CD4+ and CD8+\], CD19+, CD16+/CD56+ and further defined functional T cell subsets (naïve, central memory, effector memory and regulatory T cells)
Adverse event and safety lab monitoring
12 lead ECG and telemetry monitoring plus vital signs (systolic and diastolic blood blood pressures), heart rate, respiratory rate and temperature
Peak blood concentration, time of peak blood concentration, oral clearance, half life and AUC
Reduction from baseline in lymphocyte counts obtained at different time points after dosing and at different dose levels
| Arm | Type | Description |
|---|---|---|
| GSK2018682 | ACTIVE_COMPARATOR | Active Drug |
| Placebo Control | PLACEBO_COMPARATOR | Placebo |
| Part A | EXPERIMENTAL | Part A will be used to confirm the prediction of GSK2018682 PK, assess its effects on lymphocytes, and monitor its safety profile in a single cohort (Cohort 1). Cohort 1 will consist of 4 subjects and explore 4 doses of GSK2018682 in 4 study sessions. In each session, three subjects will receive GSK2018682 and one subject will receive placebo. Thus, when the cohort completes, each subject will receive placebo and 3 doses of GSK2018682. |
| Part B | EXPERIMENTAL | Part B will explore doses to refine the dose-response curve of GSK2018682 on lymphocyte suppression, as allowed by stopping criteria, in 1 or 2 cohorts of up to 15 subjects (Cohort 2 and Cohort 3). In Part B, up to six single ascending doses of GSK2018682 and one dose of placebo will be investigated in up to 8 sessions. |
| Name | Type | Description |
|---|---|---|
| GSK2018682 | DRUG | Active Drug |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * Females must be of non-childbearing potential. * BMI within the range 19 - 29 kg/m2 (incl...
GSK2018682 is an investigational small molecule being developed for multiple sclerosis, including relapsing-remitting multiple sclerosis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
GSK2018682 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting early-stage clinical trials to evaluate the drug's safety and tolerability.
GSK2018682 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug remains investigational and has not received regulatory approval for any indication.
GSK2018682 has been studied in two completed Phase 1 trials: NCT01387217, a first-time-in-human study in healthy volunteers, and NCT01431937, a repeat ascending dose study. Both trials were conducted in Australia and enrolled a total of 40 participants.
No alternative names for GSK2018682 have been disclosed. The drug is identified solely by its development code GSK2018682 in clinical trial registries and scientific literature.