Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK3074477- 1 · 1 trial · 1 indication
PK parameters include: area under the plasma concentration curve (AUC\[0-infinity\], AUC\[0-t\]), maximum observed concentration (Cmax).
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Four subjects (2 Chinese and 2 Caucasian) will receive one amlodipine 10mg tablet and one rosuvastatin 20mg tablet in Period 1; one GSK3074477 Fixed dose combination (FDC) formulation-1 tablet in Period 2 and one GSK3074477 FDC formulation-2 tablet in Period 3; all treatments will be administered orally in fasted state. The three treatment periods will be separated by a washout period of between 12-17 days. |
| Sequence 2 | EXPERIMENTAL | Four subjects (2 Chinese and 2 Caucasian) will receive one amlodipine 10mg tablet and one rosuvastatin 20mg tablet in Period 1; one GSK3074477 FDC formulation-2 tablet in Period 2 and one GSK3074477 FDC formulation-1 tablet in Period 3; all treatments will be administered orally in fasted state. The three treatment periods will be separated by a washout period of between 12-17 days. |
| Sequence 3 | EXPERIMENTAL | Four subjects (2 Chinese and 2 Caucasian) will receive one GSK3074477 FDC formulation-1 tablet in Period 1, one amlodipine 10mg tablet and one rosuvastatin 20mg tablet in Period 2; and one GSK3074477 FDC formulation-2 tablet in Period 3; all treatments will be administered orally in fasted state. The three treatment periods will be separated by a washout period of between 12-17 days. |
| Sequence 4 | EXPERIMENTAL | Four subjects (2 Chinese and 2 Caucasian) will receive one GSK3074477 FDC formulation-1 tablet in Period 1; one GSK3074477 FDC formulation-2 tablet in Period 2; and one amlodipine 10mg tablet and one rosuvastatin 20mg tablet in Period 3; all treatments will be administered orally in fasted state. The three treatment periods will be separated by a washout period of between 12-17 days. |
| Sequence 5 | EXPERIMENTAL | Four subjects (2 Chinese and 2 Caucasian) will receive one GSK3074477 FDC formulation-2 tablet in Period 1; one amlodipine 10mg tablet and one rosuvastatin 20mg tablet in Period 2; and one GSK3074477 FDC formulation-1 tablet in Period 3; all treatments will be administered orally in fasted state. The three treatment periods will be separated by a washout period of between 12-17 days. |
| Sequence 6 | EXPERIMENTAL | Four subjects (2 Chinese and 2 Caucasian) will receive one GSK3074477 FDC formulation-2 tablet in Period 1; one GSK3074477 FDC formulation-1 tablet in Period 2; and one amlodipine 10mg tablet and one rosuvastatin 20mg tablet in Period 3; all treatments will be administered orally in fasted state. The three treatment periods will be separated by a washout period of between 12-17 days. |
| Name | Type | Description |
|---|---|---|
| Amlodipine+Rosuvastatin | DRUG | Amlodipine 10mg will be supplied as white or off-white, emerald shaped tablet. Rosuvastatin 20mg will be supplied as pink round film coated tablet. |
| GSK3074477 FDC - 1 | DRUG | GSK3074477 containing combination of 10mg amlodipine and 20mg rosuvastatin, will be supplied as white caplet shaped film coated tablet. |
| GSK3074477 FDC - 2 | DRUG | GSK3074477 containing combination of 10mg amlodipine and 20mg rosuvastatin, will be supplied as white caplet shaped film coated tablet. |
Inclusion Criteria: * Male or female between 21 and 65 years of age inclusive, at the time of signing the informed consent. * Alanine transaminase, alkaline phosphatase and total bilirubin \<=1.5x upper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated a...
GSK3074477-1 is a small molecule being developed for the treatment of hypertension, a cardiovascular condition characterized by high blood pressure. It is currently in Phase 1 clinical development and is being studied in healthy volunteers to assess its bioavailability and pharmacokinetic profile.
GSK3074477-1 is a small molecule, but its specific molecular target has not been disclosed. The drug is being investigated for hypertension, and its mechanism of action is not publicly detailed at this time.
GSK3074477-1 is being developed by GSK plc, a global biopharmaceutical company. GSK plc is listed on the stock exchange under the ticker symbol GSK.
GSK3074477-1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
GSK3074477-1 has one completed Phase 1 clinical trial, identified as NCT02075619. This was a relative bioavailability study comparing amlodipine and rosuvastatin fixed-dose combinations in healthy subjects under fasting conditions. The trial enrolled 24 participants and was conducted in Singapore.
GSK3074477-1 is not the same as amlodipine or rosuvastatin. The Phase 1 trial studied the relative bioavailability of amlodipine and rosuvastatin tablets compared to fixed-dose combinations of these two drugs, but GSK3074477-1 is a separate investigational compound being developed for hypertension.