TABLE 1.
Summary of pharmacokinetic variables of daridorexant administered as single oral dose of 25 mg to control subjects (N = 7) and patients with SRFI (N = 8)
|
Control subjects (Group A, N = 7) a |
Patients with SRFI (Group B, N = 8) a |
Ratio of geometric means (90% CI), B/A b | |
|---|---|---|---|
| Cmax, ng/ml | 794 (445–1417) | 744 (573–965) | 0.94 (0.60–1.46) |
| T max, h | 0.75 (0.50–3.00) | 0.75 (0.50–1.50) | −0.25 (−0.75–0.25) |
| AUC0‐t, ng·h/ml | 5783 (2741–12,199) | 7000 (5136–9541) | 1.21 (0.69–2.12) |
| AUC0‐inf, ng·h/ml | 6223 (2780–13,931) | 7192 (5138–10,068) | 1.16 (0.63–2.12) |
| t ½, h | 11.4 (7.57–17.1) | 11.2 (7.74–16.3) | 0.99 (0.66–1.48) |
| CL/F, L/h | 4.01 (1.79–8.99) | 3.48 (2.48–4.87) | 0.87 (0.47–1.59) |
| Vz/F, L | 65.9 (43.8–99.1) | 56.2 (49.1–64.3) | 0.85 (0.64–1.15) |
Abbreviations: AUC0‐inf, area under the plasma concentration‐time curve from zero to infinity; AUC0‐t, area under the plasma concentration‐time curve from zero to time t of the last measured concentration above the limit of quantification; CI, confidence interval; CL/F, apparent total plasma clearance; Cmax, maximum plasma concentration; SRFI, severe renal function impairment; t ½, terminal half‐life; T max, time to reach maximum plasma concentration; V z/F, apparent volume of distribution.
Data are presented as geometric mean (95% CI) except for T max: median (range).
Data are presented as geometric mean ratios (B/A; 90% CI) except for T max: median difference (B‐A; 90% CI).