Pharmacokinetics and Safety of a Single Oral Dose of Mirogabalin in Japanese Subjects With Varying Degrees of Renal Impairment.

ABSTRACT: Mirogabalin (DS-5565) is a novel preferentially selective α₂ δ-1 ligand being developed for the treatment of diabetic peripheral neuropathic pain and postherpetic neuralgia. The current multicenter open-label study determined the effect of varying degrees of renal impairment on the pharmacokinetics and safety of a single dose of mirogabalin 5 mg in Japanese subjects. A total of 30 subjects (6 subjects per renal function category [normal, mild, moderate, or severe impairment; and end-stage renal disease (ESRD)]) were enrolled and completed the study. The AUC_last increased with severity of renal impairment; the geometric least-squares mean ratios of AUC_last compared with subjects with normal renal function were 1.3, 1.9, 3.6, and 5.3 for patients with mild, m

SUBMITTER: Kato M 

PROVIDER: S-EPMC5763271 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature