Table S2.
Mean plasma and urine levels of olanzapine and samidorphan in subjects with severe renal impairment and healthy control subjects after a single oral dose of OLZ/SAM (5 mg olanzapine/10 mg samidorphan)
| Arithmetic mean (SD) postdose plasma concentration (ng/mL) | ||||
|---|---|---|---|---|
| Olanzapine | Samidorphan | |||
| Severe renal impairment (N=10) | Healthy control (N=10) | Severe renal impairment (N=10) | Healthy control (N=10) | |
| Time postdose, hr | ||||
| 0 (predose) | <LLOQ | <LLOQ | <LLOQ | <LLOQ |
| 0.5 | 0.38 (0.56) | <LLOQ | 17.38 (16.93) | 15.30 (12.21) |
| 1 | 1.66 (1.76) | 0.96 (1.14) | 24.55 (12.33) | 21.64 (8.48) |
| 2 | 3.64 (3.57) | 3.04 (2.39) | 25.72 (9.21) | 19.4 (5.73) |
| 3 | 4.89 (3.92) | 3.49 (1.24) | 28.02 (6.01) | 17.62 (4.39) |
| 4 | 5.61 (4.27) | 3.92 (1.21) | 27.07 (4.64) | 14.92 (2.96) |
| 5 | 6.01 (2.98) | 3.97 (1.40) | 24.95 (4.26) | 12.60 (1.86) |
| 6 | 6.31 (2.76) | 3.80 (1.10) | 23.03 (3.48) | 11.28 (2.15) |
| 7 | 5.85 (2.56) | 3.99 (0.94) | 19.61 (2.02) | 9.68 (1.40) |
| 8 | 5.83 (2.13) | 4.10 (0.81) | 19.48 (3.45) | 8.82 (1.38) |
| 12 | 4.31 (1.53) | 3.74 (0.73) | 13.38 (2.76) | 5.85 (1.21) |
| 16 | 4.00 (1.49) | 2.95 (0.60) | 10.36 (2.16) | 4.05 (0.92) |
| 24 | 3.74 (1.34) | 2.68 (0.43) | 6.84 (1.59) | 2.49 (0.76) |
| 36 | 3.32 (1.20) | 2.07 (0.46) | 3.72 (1.26) | 1.13 (0.52) |
| 48 | 2.68 (0.88) | 1.91 (0.51) | 2.20 (0.95) | 0.59 (0.36) |
| 72 | 1.93 (0.78) | 1.30 (0.37) | 0.87 (0.57) | <LLOQ |
| 96 | 1.42 (0.57) | 0.87 (0.33) | 0.30 (0.33) | <LLOQ |
| 120 | 1.05 (0.32) | 0.63 (0.28) | <LLOQ | <LLOQ |
| 168 | 0.62 (0.30) | <LLOQ | <LLOQ | <LLOQ |
| Arithmetic mean (SD) postdose urine concentration (ng/mL) | ||||
| Time postdose, hr | ||||
| 0 (predose) | <LLOQ | <LLOQ | <LLOQ | <LLOQ |
| 0‒4 | 23.10 (19.81) | 9.07 (9.58) | 432.45 (213.66) | 461.10 (224.40) |
| 4‒8 | 84.81 (69.96) | 33.21 (36.45) | 573.67 (398.33) | 593.80 (197.93) |
| 8‒12 | 60.21 (30.98) | 58.91 (29.86) | 409.40 (110.92) | 720.00 (255.28) |
| 12‒16 | 60.39 (26.00) | 106.21 (73.04) | 340.43 (107.58) | 699.33 (433.96) |
| 16‒24 | 47.65 (18.60) | 85.11 (50.09) | 273.67 (98.91) | 490.90 (389.37) |
| 24‒36 | 45.08 (22.70) | 55.95 (30.92) | 145.72 (92.07) | 199.36 (66.83) |
| 36‒48 | 38.19 (21.65) | 57.13 (43.77) | 85.57 (38.76) | 119.11 (96.76) |
| 48‒60 | 36.22 (18.30) | 29.04 (18.53) | 56.02 (39.05) | 54.85 (43.34) |
| 60‒72 | 31.11 (21.37) | 21.87 (20.97) | 34.84 (22.85) | 30.44 (34.11) |
| 72‒84 | 28.57 (14.73) | 19.21 (14.88) | 26.10 (21.94) | 12.52 (8.37) |
| 84‒96 | 20.09 (13.57) | 12.95 (7.83) | 15.33 (13.81) | 11.61 (15.74) |
| 96‒108 | 15.60 (9.67) | 10.49 (7.70) | 7.96 (7.24) | 6.39 (7.20) |
| 108‒120 | 13.62 (11.22) | 10.66 (6.73) | 5.82 (5.45) | 4.33 (6.43) |
| 120‒132 | 12.67 (6.10) | 11.57 (5.71) | 4.30 (3.65) | 4.02 (8.12) |
| 132‒144 | 10.70 (9.51) | 9.84 (5.94) | 2.88 (3.47) | 3.23 (6.25) |
| 144‒156 | 8.91 (4.87) | 5.53 (3.73) | <LLOQ | <LLOQ |
| 156‒168 | 7.12 (3.58) | 7.99 (4.55) | <LLOQ | 2.95 (7.33) |
Notes: Values below the LLOQ (0.250 ng/mL for plasma and 2.50 ng/mL for urine) were set to 0 in the calculation of the summary statistics.
Abbreviation: LLOQ, lower limit of quantification.