TABLE 2.
Summary of treatment-emergent adverse events.
Single dose | Multiple-dose | Total | |||
---|---|---|---|---|---|
1.5 mg (N = 12) | 2.5 mg a (N = 12) | 5 mg (N = 12) | 2.5 mg (N = 12) | N = 49 | |
Number of subjects (percent) | |||||
Any AEs | 2 (16.7) | 7 (58.3) | 8 (66.7) | 8 (61.5) | 25 (51.0) |
Dizziness | 0 (0) | 0 (0) | 4 (33.3) | 0 (0) | 4 (8.2) |
hyperuricemia | 0 (0) | 1 (8.3) | 2 (16.7) | 0 (0) | 3 (6.1) |
Upper respiratory tract infection | 0 (0) | 1 (8.3) | 0 (0) | 2 (15.4) | 3 (6.1) |
Myalgia | 0 (0) | 0 (0) | 0 (0) | 1 (7.7) | 1 (2.0) |
Nasal obstruction | 0 (0) | 0 (0) | 0 (0) | 1 (7.7) | 1 (2.0) |
Sinus tachycardia | 0 (0) | 0 (0) | 0 (0) | 1 (7.7) | 1 (2.0) |
Ocular hypertension | 0 (0) | 1 (8.3) | 0 (0) | 0 (0) | 1 (2.0) |
DBP decreased | 0 (0) | 0 (0) | 1 (8.3) | 2 (15.4) | 3 (6.1) |
ECG PR shortened | 0 (0) | 1 (8.3) | 0 (0) | 0 (0) | 1 (2.0) |
ECG T wave abnormal | 0 (0) | 0 (0) | 0 (0) | 1 (7.7) | 1 (2.0) |
Heart rate decreased | 0 (0) | 0 (0) | 0 (0) | 1 (7.7) | 1 (2.0) |
Heart rate increased | 1 (8.3) | 1 (8.3) | 0 (0) | 0 (0) | 2 (4.1) |
Blood bilirubin increased | 1 (8.3) | 0 (0) | 0 (0) | 0 (0) | 1 (2.0) |
Blood TG increased | 0 (0) | 0 (0) | 2 (16.7) | 1 (7.7) | 3 (6.1) |
CRE increased | 0 (0) | 2 (16.7) | 0 (0) | 0 (0) | 2 (4.1) |
ALT increased | 0 (0) | 1 (8.3) | 0 (0) | 0 (0) | 1 (2.0) |
RBC urine positive | 0 (0) | 1 (8.3) | 2 (16.7) | 0 (0) | 3 (6.1) |
WBC urine positive | 0 (0) | 1 (8.3) | 1 (8.3) | 0 (0) | 2 (4.1) |
MC count increased | 0 (0) | 0 (0) | 0 (0) | 1 (7.7) | 1 (2.0) |
Urinary sediment present | 0 (0) | 1 (8.3) | 0 (0) | 0 (0) | 1 (2.0) |
Protein urine present | 0 (0) | 0 (0) | 1 (8.3) | 0 (0) | 1 (2.0) |
DBP: diastolic blood pressure; ECG: electrocardiogram; TG: triglycerides; CRE: serum creatinine; ALT: alanine aminotransferase; RBC: red blood cells; WBC: white blood cells; MC: mononuclear cell.
AEs, were counted for both fasted and fed phase after the single dose administration of dimdazenil.