NCT02075619.
Methods | Open‐label, single‐centre, randomised, single‐dose, three‐way cross‐over, six‐sequence study |
Participants |
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Interventions |
Experimental: Sequence 1 Four participants (2 Chinese and 2 white) will receive 1 amlodipine 10 mg tablet and 1 rosuvastatin 20 mg tablet in Period 1; 1 GSK3074477 fixed‐dose combination (FDC) formulation‐1 tablet in Period 2 and 1 GSK3074477 FDC formulation‐2 tablet in Period 3; all treatments will be administered orally in fasted state. The 3 treatment periods will be separated by a washout period of between 12‐17 days Experimental: Sequence 2 Four participants (2 Chinese and 2 white) will receive 1 amlodipine 10 mg tablet and 1 rosuvastatin 20 mg tablet in Period 1; 1 GSK3074477 FDC formulation‐2 tablet in Period 2 and 1 GSK3074477 FDC formulation‐1 tablet in Period 3; all treatments will be administered orally in fasted state. The 3 treatment periods will be separated by a washout period of between 12‐17 days Experimental: Sequence 3 Four participants (2 Chinese and 2 white) will receive 1 GSK3074477 FDC formulation‐1 tablet in Period 1, 1 amlodipine 10 mg tablet and 1 rosuvastatin 20 mg tablet in Period 2; and 1 GSK3074477 FDC formulation‐2 tablet in Period 3; all treatments will be administered orally in fasted state. The 3 treatment periods will be separated by a washout period of between 12‐17 days Experimental: Sequence 4 Four participants (2 Chinese and 2 white) will receive 1 GSK3074477 FDC formulation‐1 tablet in Period 1; 1 GSK3074477 FDC formulation‐2 tablet in Period 2; and 1 amlodipine 10 mg tablet and 1 rosuvastatin 20 mg tablet in Period 3; all treatments will be administered orally in fasted state. The 3 treatment periods will be separated by a washout period of between 12‐17 days Experimental: Sequence 5 Four participants (2 Chinese and 2 white) will receive 1 GSK3074477 FDC formulation‐2 tablet in Period 1; 1 amlodipine 10 mg tablet and 1 rosuvastatin 20 mg tablet in Period 2; and 1 GSK3074477 FDC formulation‐1 tablet in Period 3; all treatments will be administered orally in fasted state. The 3 treatment periods will be separated by a washout period of between 12‐17 days Experimental: Sequence 6 Four participants (2 Chinese and 2 white) will receive 1 GSK3074477 FDC formulation‐2 tablet in Period 1; 1 GSK3074477 FDC formulation‐1 tablet in Period 2; and 1 amlodipine 10 mg tablet and 1 rosuvastatin 20 mg tablet in Period 3; all treatments will be administered orally in fasted state. The 3 treatment periods will be separated by a washout period of between 12‐17 days |
Outcomes |
Primary outcomes:
Secondary outcomes:
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Notes |