Details

Autor(en) / Beteiligte

• Zhang, Peijin
• Hosein, Fareeda
• Yu, Kyungha
• Walker, Susan
• Syto, Mary
• Tirucherai, Giridhar
• Murthy, Bindu
• Tatosian, Daniel

Titel

S1107 Effect of Mild or Moderate Hepatic Impairment on the Pharmacokinetics of Ozanimod

Ist Teil von

• The American journal of gastroenterology, 2023-10, Vol.118 (10S), p.S843-S843

Ort / Verlag

New York: Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins

Erscheinungsjahr

2023

Beschreibungen/Notizen

• Methods: This multicenter, open-label phase 1 study (NCT04639115) evaluated the effect of mild (Child-Pugh score 5–6) or MOD (Child-Pugh score 7–9) HI on the multiple-dose pharmacokinetics (PK) of OZA and its 2 major active METs. Analysis of variance fitted to the natural log-transformed PK parameters with HF group as the fixed effect and the matching pair as a random effect compared PK parameters between groups. Ratio of geometric LS mean (90% CI) for unbound PK parameters in ptps with HI vs matched healthy ptps Group comparison PK parameter of interest OZA CC112273 CC1084037 Mild hepatic impairment (test) vs normal matched (reference) D1 Cmax 134.42 (108.51–166.52) 118.03 (77.19–180.47) NA D5 Cmax 135.60 (106.51–172.63) 135.50 (92.26–198.99) 141.26 (95.86–208.17) D8 Cmax 186.48 (103.75–335.19) 147.45 (87.15–249.47) 145.26 (90.38–233.45) D8 AUC0-last,u 182.53 (81.97–406.46) 221.43 (106.61–459.88) 229.74 (93.24–566.10) MOD hepatic impairment (test) vs normal matched (reference) D1 Cmax 136.12 (110.49–167.71) 113.96 (85.55–151.81) NA D5 Cmax 124.92 (93.42–167.04) 111.73 (80.73–154.61) 120.98 (96.42–151.80) D8 Cmax 168.91 (95.72–298.09) 133.71 (84.78–210.88) 135.77 (94.20–195.68) D8 AUC0-last,u 145.87 (68.28–311.64) 199.64 (119.55–333.37) 212.36 (118.15–381.70) The log-transformed PK parameters were analyzed using an ANOVA model with HF group as a fixed effect and matching pair as a random effect.