Table 1.
Summary of Study Population Demographics
| Subject Group | Treatment Dose and Route | Number of Subjects Enrolleda | Age Range (Years) | Mean Weight, kg (SD) | Mean BMI, kg/m2 (SD) | Female, n (%) | Male, n (%) |
|---|---|---|---|---|---|---|---|
| Renal insufficiency (all) | 37.5 mg HPβCD‐diclofenac IV | 13 | 50–75 | 79.8 (20.2) | 28.3 (5.4) | 8 (61.5) | 5 (38.5) |
| Mild renal insufficiencyb | 37.5 mg HPβCD‐diclofenac IV | 8 | 57–75 | 70.8 (12.6) | 25.9 (3.7) | 5 (62.5) | 3 (37.5) |
| Moderate renal insufficiencyc | 37.5 mg HPβCD‐diclofenac IV | 5 | 50–75 | 94.1 (23.1) | 32.0 (5.9) | 3 (60.0) | 2 (40.0) |
| Hepatic impairmentd | 37.5 mg HPβCD‐diclofenac IV | 8 | 40–61 | 76.4 (12.2) | 25.1 (4.4) | 0 | 8 (100.0) |
| Healthy | 37.5 mg HPβCD‐diclofenac IV | ||||||
| 200 mg itraconazole IV | 19 | 33–65 | 74.9 (10.0) | 25.5 (3.0) | 6 (31.6) | 13 (68.4) |
BMI, body mass index; IV, intravenous.
a
Number of subjects screened in renal insufficiency, hepatic impairment, and healthy control groups was 27, 14, and 43, respectively.
b
Mild renal insufficiency: creatinine clearance (CrCl) ≥ 50 and < 80 mL/min.
c
Moderate renal insufficiency: CrCl ≥ 30 and < 50 mL/min.
d
Mild hepatic impairment: Child‐Pugh Classification A score 5–6; serum bilirubin ≤ 2.5 mg/dL.