Table 1.
Summary of Baseline Demographics and Subject Characteristics in the Renal Impairment Study and Hepatic Impairment Study
| Renal Impairment Study | |||
|---|---|---|---|
| Parameter | ESRD Subjects | Healthy Subjects | Total |
| Number | 9 | 8 | 17 |
| Oliceridine dose (IV) | 0.5 mg | 1 mg | |
| Sex, n (%) | |||
| Male | 8 (88.9) | 7 (87.5) | 15 (88.2) |
| Female | 1 (11.1) | 1 (12.5) | 2 (11.8) |
| Race, n (%) | |||
| Black | 4 (44.4) | 5 (62.5) | 9 (52.9) |
| White | 3 (33.3) | 2 (25.0) | 5 (29.4) |
| Other | 2 (22.2) | 1 (12.5) | 3 (17.6) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 2 (22.2) | 2 (25.0) | 4 (23.5) |
| Not Hispanic or Latino | 7 (77.8) | 6 (75.0) | 13 (76.5) |
| Age, y | |||
| Mean (SD) | 49.6 (5.70) | 45.9 (6.96) | 47.8 (6.41) |
| Median | 50.0 | 45.5 | 47.0 |
| Min‐max | 42‐60 | 34‐54 | 34‐60 |
| Weight, kg | |||
| Mean (SD) | 84.7 (13.2) | 84.4 (9.8) | 84.5 (11.3) |
| Median | 86.7 | 83.8 | 85.4 |
| Min‐max | 65.6‐101.3 | 70.6‐96.8 | 65.6‐101.3 |
| Body mass index (kg/m2) | |||
| Mean (SD) | 27.7 (5.2) | 27.2 (4.7) | 27.4 (4.8) |
| Median | 27.0 | 27.5 | 27.4 |
| Min‐max | 20.7‐34.5 | 20.4‐33.7 | 20.4‐34.5 |
| eGFR (mL/[min/1.73 m2]) | |||
| Mean (SD) | 7.8 (3.4) | 100.3 (20.8) | 51.3 (49.6) |
| Median | 8.0 | 101.5 | 14.0 |
| Min‐max | 4‐14 | 69‐138 | 4‐138 |
| CLcr (mL/min) | |||
| Mean (SD) | 13.0 (3.94) | 120.9 (21.01) | 63.8 (57.28) |
| Median | 13.0 | 118.0 | 19.0 |
| Min‐max | 7‐19 | 95‐157 | 7‐157 |
| Hepatic Impairment Group | Healthy Subjects | |||
|---|---|---|---|---|
| Hepatic impairment | Mild | Moderate | Severe | Normal |
| Child‐Pugh class | 5‐6 | 7‐9 | 10‐15 | Not applicable |
| Number | 10 | 10 | 6 | 8 |
| Oliceridine dose (IV) | 0.5 mg | 0.5 mg | 0.5 mg | 1 mg |
| Sex | ||||
| Male, n (%) | 6 (60) | 7 (70) | 4 (66.7) | 4 (50) |
| Female, n (%) | 4 (40) | 3 (30) | 2 (33.3) | 4 (50) |
| Race | ||||
| White, n (%) | 10 (100) | 10 (100) | 6 (100) | 8 (100) |
| Ethnicity | ||||
| Not Hispanic or Latino | 10 (100) | 10 (100) | 6 (100) | 8 (100) |
| Age, y | ||||
| Mean (SD) | 55.7 (9.8) | 58.3 (10.2) | 54.8 (4.2) | 55.5 (9.7) |
| Median | 56 | 62 | 54 | 58 |
| Min‐max | 36‐71 | 33‐67 | 49‐61 | 42‐66 |
| Weight (kg) | ||||
| Mean (SD) | 77.8 (19.5) | 80.5 (18.5) | 78.3 (23.0) | 78.3 (15.5) |
| Median | 73.4 | 75.0 | 74.8 | 82.0 |
| Min‐max | 55.0‐114.0 | 53.0‐118.0 | 57.0‐119.5 | 58.0‐101.0 |
| Body mass index (m/kg2) | ||||
| Mean (SD) | 26.9 (4.8) | 27.2 (5.2) | 26.5 (5.9) | 27.5 (3.8) |
| Median | 26.8 | 26.4 | 29.0 | 28.8 |
| Min‐max | 20.8‐34.4 | 21.0‐34.1 | 19.0‐33.3 | 21.2‐31.5 |
CLcr indicates creatinine clearance as calculated by Cockcroft‐Gault equation; eGFR, estimated glomerular filtration rate; ESRD, end‐stage renal disease (chronic kidney disease stage 5 on chronic hemodialysis); IV, intravenous.