Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK1278863A · 4 trials · 2 indications
Platelet Count , RBC Indices, WBC Differential, RBC Count, WBC Count, Lymphocytes, Reticulocyte Count, Hemoglobin, Hematocritm, BUN, Ptassium, AST, Total and direct bilirubin, Creatinine, Chloride, ALT, Uric Acid, Glucose, Total CO2, GGT, Albumin, Sodium, Calcium, Alkaline phosphatase, Total Protein, CPK, Iron Ferritin, TIBC
systolic and diastolic blood pressure and pulse rate
To determine the relative bioavailability of GSK1278863A after single oral doses of 100 mg GSK1278863A tablets with particle sizes of 13, 29 and 41um in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| GSK1278863A Placebo | PLACEBO_COMPARATOR | 5, 25 and 100 mg matched |
| GSK1278863A 10mg | EXPERIMENTAL | A round, biconvex, white film coated tablet |
| GSK1278863A 25mg | EXPERIMENTAL | A round, biconvex, white film coated tablet |
| GSK1278863A 50mg | EXPERIMENTAL | A round, biconvex, white film coated tablet |
| GSK1278863A 100mg | EXPERIMENTAL | A round, biconvex, white film coated tablet |
| GSK1278863A 100mg (X90=13um) | EXPERIMENTAL | single dose |
| GSK1278863A 100mg (x90=29Um) | EXPERIMENTAL | single dose |
| GSK1278863 100mg (X90=41um) | EXPERIMENTAL | single dose |
| Subjects with renal impairment, non-dialysis | EXPERIMENTAL | Subjects with moderate to severe renal impairment equivalent to National Kidney Foundation Kidney Disease Outcomes Quality Initiative stage 3 and stage 4 who are not undergoing dialysis will be included. Subjects will receive single 50 mg and 150 mg oral doses of GSK1278863A across two dosing periods in a single-blind, randomized sequence. Doses of GSK1278863A will be given as 25 mg and 100 mg tablets, with matching placebo tablets to maintain treatment blinding. |
| Healthy volunteers | EXPERIMENTAL | Healthy subjects will be matched to the moderate and severe renally impaired subjects for gender, age, and BMI. Subjects will receive single 50 mg and 150 mg oral doses of GSK1278863A across two dosing periods in a single-blind, randomized sequence. Doses of GSK1278863A will be given as 25 mg and 100 mg tablets, with matching placebo tablets to maintain treatment blinding. |
| Hemodialysis dependent subjects | EXPERIMENTAL | The arm will consist of subjects with severe renal impairment (end-stage renal failure) who have been on stable hemodialysis treatment scheduled three times per week. Subjects will receive single oral doses of 150 mg GSK1278863A in each of 2 dosing periods in an open-label, fixed sequence. GSK1278863A will be administered just prior to receiving scheduled hemodialysis in Dosing Period 1. In Dosing Period 2, subjects will receive a single oral dose of GSK1278863 the morning after completion of a scheduled hemodialysis session. |
| Cohorts | EXPERIMENTAL | This study will be a single-blind, randomized, placebo-controlled, dose-rising, single dose, parallel group study with 6 proposed Cohorts from 2mg to 450mg. |
| Name | Type | Description |
|---|---|---|
| GSK1278863A Placebo | DRUG | Matching size, shape and color |
| GSK1278863A | DRUG | A round, biconvex, white film coated tablet |
| Placebo | DRUG | matching placebo |
Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin \>1.5xULN. * Healthy Male or female between 20 and 65 years of age inclusive, at the time of signing the informed consent. * Male subjects with female partners of child-bearing potential must agree to use one of the contraception me...
GSK1278863A is an investigational small molecule being developed for kidney disease and anemia. It is in Phase 1 clinical development, with completed studies in healthy subjects and patients with renal impairment. The drug is not approved and remains under clinical investigation.
GSK1278863A is developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker GSK. The drug is currently in Phase 1 clinical development for kidney disease and anemia.
GSK1278863A is in Phase 1 clinical development. All three completed trials were Phase 1 studies, including safety, tolerability, pharmacokinetics, and pharmacodynamics assessments. The drug is investigational and not yet approved for any use.
GSK1278863A has completed three Phase 1 trials: NCT00750256 in healthy subjects with anemia, NCT00935831 in patients with renal impairment and kidney disease, and NCT01319006, a relative bioavailability study in healthy subjects. All trials are completed.
GSK1278863A is an investigational compound studied for anemia and kidney disease. No alternative names have been established for this drug in the available data. It is distinct from other agents and remains in early clinical development.