Table 2.
Gastrointestinal-related treatment-emergent adverse events in humans after a single dose (a) or multiple ascending doses (b) of placebo and AMG 133
| a | |||||||
|---|---|---|---|---|---|---|---|
| Placebo (n = 12) | 21 mg (n = 6) | 70 mg (n = 6) | 140 mg (n = 7) | 280 mg (n = 6) | 560 mg (n = 6) | 840 mg (n = 6) | |
| Number of individuals reporting TEAEs | 3 (25.0) | 0 (0.0) | 2 (33.3) | 5 (71.4) | 6 (100.0) | 5 (83.3) | 6 (100.0) |
| GI disorders | |||||||
| Diarrhoea | 2 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Dyspepsia | 1 (8.3) | 0 (0.0) | 1 (16.7) | 4 (57.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Abdominal discomfort | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (28.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Constipation | 1 (8.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 3 (50.0) |
| Gastroesophageal reflux disease | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
| Nausea | 3 (25.0) | 0 (0.0) | 2 (33.3) | 4 (57.1) | 4 (66.7) | 5 (83.3) | 5 (83.3) |
| Vomiting | 0 (0.0) | 0 (0.0) | 1 (16.7) | 4 (57.1) | 5 (83.3) | 5 (83.3) | 4 (66.7) |
| GI safety laboratory | |||||||
| Amylase elevation | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (14.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Lipase elevation | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (14.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Hepatic enzyme elevation | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
| b | ||||
|---|---|---|---|---|
| Placebo (n = 6) | 140 mg (n = 6) | 280 mg (n = 6) | 420 mg (n = 8) | |
| Number of individuals reporting TEAEs | 3 (50.0) | 6 (100.0) | 6 (100.0) | 8 (100.0) |
| GI disorders | ||||
| Diarrhoea | 0 (0.0) | 1 (16.7) | 0 (0.0) | 2 (25.0) |
| Dyspepsia | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (12.5) |
| Abdominal distension | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (12.5) |
| Abdominal pain upper | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) |
| Constipation | 0 (0.0) | 2 (33.3) | 1 (16.7) | 0 (0.0) |
| Nausea | 1 (16.7) | 5 (83.3) | 4 (66.7) | 8 (100.0) |
| Vomiting | 0 (0.0) | 4 (66.7) | 5 (83.3) | 6 (75.0) |
| GI safety laboratory | ||||
| Amylase elevation | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
| Lipase elevation | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Data show number (%) of participants with the event of interest.