TABLE 2.
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 AE | 4 (17) | 2 (40) | 3 (100) | 2 (33) | 3 (50) | 8 (67) | 4 (67) | 3 (50) |
Any nonserious treatment‐related AE | 1 (4) | 0 | 1 (33) | 0 | 0 | 0 | 0 | 0 |
Diarrhoea | 0 | 0 | 1 (33) | 0 | 0 | 0 | 0 | 0 |
Nausea | 0 | 0 | 1 (33) | 0 | 0 | 0 | 0 | 0 |
Transaminase increased | 1 (4) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
AEs leading to withdrawal | 0 | 1 (20) | 0 | 1 (17) | 0 | 0 | 0 | 0 |
Neutropenia | 0 | 1 (20) | 0 | 0 | 0 | 0 | 0 | 0 |
Ventricular tachycardia (nonsustained) | 0 | 0 | 0 | 1 (17) | 0 | 0 | 0 | 0 |
PART C d | ||
---|---|---|
Adverse event, n (%) c | Placebo (N = 11) | GSK3358699 10 mg QD (N = 14) |
Any AE | 7 (64) | 7 (50) |
Any nonserious treatment‐related AE | 3 (27) | 3 (21) |
Tachycardia | 1 (9) | 1 (7) |
Atrial fibrillation | 1 (9) | 0 |
Palpitations | 1 (9) | 0 |
Ventricular extrasystoles | 0 | 1 (7) |
Ventricular tachycardia (nonsustained) | 0 | 1 (7) |
Serious AE | 0 | 1 (7) |
Atrial fibrillation | 0 | 1 (7) |
AEs leading to withdrawal | 1 (9) | 3 (21) |
Atrial fibrillation | 0 | 1 (7) |
Tachycardia | 0 | 1 (7) |
Ventricular tachycardia (nonsustained) | 0 | 1 (7) |
Keratitis | 1 (9) | 0 |
Abbreviation: AE, adverse event.
The safety population consisted of all randomized participants who received at least one dose of study treatment.
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.
The data presented represent the number of participants who experienced an adverse event.
In part C, participants received 10 mg of GSK3358699 or placebo daily for up to 14 days.