Table 3.
Fecal and Urinary Excretion of Potassium in a Phase 1 Study of RLY5016 in Healthy Adults.
| RLY5016 Dose (TID) | Placebo (N = 8) | ||||
|---|---|---|---|---|---|
| 0.8 g (N = 6) | 4.2 g (N = 6) | 8.4 g (N = 6) | 16.8 g (N = 6) | ||
| Fecal potassium excretion (mg/d), mean ± SD | |||||
| Baselinea | 758.1 ± 91.5 | 794.0 ± 198.9 | 676.5 ± 114.5 | 862.0 ± 172.6 | 768.1 ± 297.9 |
| End pointb | 901.7 ± 127.6 | 1411.1 ± 279.9 | 1746.1 ± 246.6 | 2791.4 ± 309.2 | 937.4 ± 708.2 |
| Change from baseline to endpoint | 143.6 ± 96.6 | 617.2 ± 132.8c | 1069.7 ± 218.1d | 1929.4 ± 416.5d | 169.3 ± 477.2 |
| Urinary potassium excretion (mg/d), mean ± SD | |||||
| Baselinea | 3493.7 ± 570.4 | 3447.2 ± 446.6 | 3765.5 ± 325.8 | 3748.8 ± 248.5 | 3644.9 ± 468.3 |
| End pointb | 3491.8 ± 539.3 | 2914.7 ± 452.8 | 2622.4 ± 221.1 | 1792.9 ± 384.3 | 3389.3 ± 669.2 |
| Change from baseline to end point | −1.9 ± 136.6 | −532.5 ± 234.3 | −1143.2 ± 316.9d | −1955.8 ± 277.3d | −255.6 ± 518.6 |
Abbreviations: SD, standard deviation; TID, 3 times daily.
aBaseline data were collected on days 5 to 11.
bEnd point data were collected on days 13 to 19. Patiromer doses are expressed as the amount of the polymer anion.
cP < .02 versus placebo.
dP < .001 versus placebo.