TABLE 8.
Parameter | Fasting conditions | Postprandial conditions | ||||
---|---|---|---|---|---|---|
T | R | Total | T | R | Total | |
No. of subjects dosed | 36 | 36 | — | 71 | 72 | — |
No. (%) of subjects with at least 1 TEAE | 6 (16.7) | 6 (16.7) | 10 (27.8) | 10 (14.1) | 10 (13.9) | 19 (26.4) |
No. of TEAEs | 6 | 11 | 17 | 14 | 23 | 37 |
Grade 1 | 5 | 7 | 12 | 11 | 17 | 28 |
Grade 2 | 1 | 4 | 5 | 2 | 5 | 7 |
≥Grade 3 | 0 | 0 | 0 | 1 | 1 | 2 |
No. of subjects discontinued due to TEAE | 0 | 0 | 0 | 1 | 0 | 1 |
Adverse event [no. (%) of subjects, no. of AEs] | — | — | — | — | — | — |
Hypertriglyceridemia | 3 (8.3) 3 | 1 (2.8) 1 | — | 3 (4.2) 3 | 4 (5.6) 4 | — |
Hyperkalemia | 0 (0) 0 | 0 (0) 0 | — | 1 (1.4) 1 | 0 (0) 0 | — |
Monocytopenia | 0 (0) 0 | 0 (0) 0 | — | 2 (2.8) 2 | 0 (0) 0 | — |
Eosinophil count increased | 0 (0) 0 | 0 (0) 0 | — | 0 (0) 0 | 4 (5.6) 4 | — |
Proteinuria | 0 (0) 0 | 0 (0) 0 | — | 2 (2.8) 2 | 0 (0) 0 | — |
Positive acetone in the urine | 0 (0) 0 | 0 (0) 0 | — | 0 (0) 0 | 1 (1.4) 1 | — |
Urine leukocytes increased | 1 (2.8) 1 | 1 (2.8) 1 | — | 0 (0) 0 | 1 (1.4) 1 | — |
Alanine aminotransferase increased | 0 (0) 0 | 1 (2.8) 1 | — | 0 (0) 0 | 0 (0) 0 | — |
Blood basophils increased | 0 (0) 0 | 1 (2.8) 1 | — | 0 (0) 0 | 0 (0) 0 | — |
Aspartate aminotransferase increased | 0 (0) 0 | 1 (2.8) 1 | — | 0 (0) 0 | 0 (0) 0 | — |
Blood conjugated bilirubin increased | 0 (0) 0 | 2 (5.6) 2 | — | 0 (0) 0 | 2 (2.8) 2 | — |
Blood unconjugated bilirubin increased | 0 (0) 0 | 1 (2.8) 1 | — | 1 (1.4) 1 | 2 (2.8) 2 | — |
Blood total bilirubin increased | 0 (0) 0 | 1 (2.8) 1 | — | 1 (1.4) 1 | 2 (2.8) 2 | — |
Diarrhea | 1 (2.8) 1 | 1 (2.8) 1 | — | 0 (0) 0 | 0 (0) 0 | — |
Hypertension | 1 (2.8) 1 | 1 (2.8) 1 | — | 2 (2.8) 2 | 2 (2.8) 2 | — |
Rapid pulse | 0 (0) 0 | 0 (0) 0 | — | 1 (1.4) 2 | 2 (2.8) 3 | — |
Upper respiratory tract infection | 0 (0) 0 | 0 (0) 0 | — | 0 (0) 0 | 1 (1.4) 1 | — |
Eczema | 0 (0) 0 | 0 (0) 0 | — | 0 (0) 0 | 1 (1.4) 1 | — |