TABLE 1.
Demographic | Part A b total (N = 23) | Part C c | Part C total (N = 25) | |
---|---|---|---|---|
Placebo (N = 11) | GSK3358699 10 mg QD (N = 14) | |||
Age, mean (range), y | 31 (18‐45) | 39 (29‐51) | 39 (20‐55) | 39 (20‐55) |
Male, n (%) | 23 (100) | 11 (100) | 14 (100) | 25 (100) |
BMI, mean (SD), kg/m2 | 25 (3) | 25 (3) d | 25 (3) | 25 (3) |
Height, mean (SD), cm | 176 (6) | 181 (9) d | 175 (6) | 177 (8) |
Weight, mean (SD), kg | 79 (12) | 81 (14) d | 77 (14) | 79 (14) |
Ethnicity, n (%) | ||||
Hispanic or Latino | 2 (9) | 3 (27) | 0 | 3 (12) |
Not Hispanic or Latino | 21 (91) | 8 (73) | 14 (100) | 22 (88) |
Race, n (%) | ||||
Black or African American | 1 (4) | 1 (9) | 0 | 1 (4) |
White | 21 (91) | 10 (91) | 14 (100) | 24 (96) |
Multiple | 1 (4) | 0 | 0 | 0 |
Abbreviations: BMI, body mass index; QD, once daily; SD, standard deviation.
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.
In part C, participants received 10 mg of GSK3358699 or placebo daily for up to 14 days.
n = 10 for these parameters.