An open-label, single-dose study to assess the effect of hepatic impairment on the pharmacokinetics of mirogabalin

Mirogabalin is an α2δ ligand being developed to treat pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and fibromyalgia. Although mirogabalin is primarily excreted in urine as unchanged parent drug, a small fraction is also metabolized by hepatic uridine 5'-diphospho-glucuronosyltransfer ase isoforms. Hepatic impairment (HI) may also affect systemic exposure. Additionally, impaired hepatic function is common in subjects with diabetes. Therefore, a phase 1, open-label, single-dose study was conducted to compare the pharmacokinetics (PK) of mirogabalin after a single dose of 15 mg i n subjects with mild or moderate HI vs matched healthy controls for each group (n = 8 for all 4 groups).
Source: The Journal of Pain - Category: Materials Science Authors: Source Type: research