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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | Luspatercept |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Disc Medicine, Inc. | IRON | 2 | PHASE2 | DISC-0974 |
| Akebia Therapeutics, Inc. | AKBA | 2 | PHASE3 | Vadadustat |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | APG-5918 |
| Bayer | BAYRY | 1 | - | Molidustat |
GSK1278863A is an investigational small molecule being developed for kidney disease and anemia. It is being studied in healthy subjects and patients with renal impairment to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is in Phase 1 clinical development and is not yet approved.
GSK1278863A is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to investigate the drug's potential in treating anemia and kidney disease.
GSK1278863A is in Phase 1 clinical development. All three completed trials for this drug are Phase 1 studies, meaning it is still in early-stage testing. The drug is investigational and has not been approved by regulatory authorities.
GSK1278863A has been studied in three completed Phase 1 trials: NCT00750256, NCT00935831, and NCT01319006. These trials evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects and patients with renal impairment. A fourth trial, NCT02348372, also completed, assessed single oral doses in healthy subjects.
GSK1278863A is also known as daprodustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor. It is being developed by GSK plc for the treatment of anemia associated with chronic kidney disease. The drug has completed Phase 1 trials and is being investigated for its efficacy and safety.