TABLE 3.
Clinically significant adverse events reported in parts A and C of the study (safety population a )
| PART A b | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse event, n (%) c | Placebo (N = 23) | GSK3358699 | ||||||
| 1 mg (n = 5) | 3 mg (n = 3) | 10 mg (n = 6) | 20 mg (n = 6) | 25 mg (n = 12) | 30 mg (n = 6) | 40 mg (n = 6) | ||
| Any cardiac event | 0 | 0 | 1 (33) | 1 (17) | 0 | 1 (8) | 1 (17) | 0 |
| Ventricular tachycardia (nonsustained) | 0 | 0 | 0 | 1 (17) | 0 | 0 | 1 (17) | 0 |
| Palpitations | 0 | 0 | 1 (33) | 0 | 0 | 0 | 0 | 0 |
| Sinus tachycardia | 0 | 0 | 0 | 0 | 0 | 1 (8) | 0 | 0 |
| PART C d | ||
|---|---|---|
| Adverse event, n (%) c | Placebo (N = 11) | GSK3358699 10 mg QD (N = 14) |
| Any cardiac event | 3 (27) | 6 (43) |
| Tachycardia | 1 (9) | 2 (14) |
| Atrial fibrillation | 1 (9) | 1 (7) |
| Atrial tachycardia | 0 | 1 (7) |
| Palpitations | 1 (9) | 0 |
| Ventricular extrasystoles | 0 | 1 (7) |
| Ventricular tachycardia (nonsustained) | 0 | 1 (7) |
Abbreviation: QD, once daily.
a
The safety population consisted of all randomized participants who received at least one dose of study treatment.
b
Part A was a single ascending‐dose crossover study in two interlocking cohorts. Each participant received a maximum of two single ascending oral doses of GSK3358699 (1, 3, 10, 20, 40 or 30 mg) and one dose of placebo.
c
The data presented represent the number of participants who experienced an adverse event.
d
In part C, participants received 10 mg of GSK3358699 or placebo daily for up to 14 days.