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Pharmacokinetics and Safety of a Single Oral Dose of Peficitinib (ASP015K) in Japanese Subjects with Normal and Impaired Renal Function. | LitMetric

AI Article Synopsis

  • This study evaluated the safety and exposure of the drug peficitinib, a new oral medication, in individuals with both normal and impaired kidney function after taking a single 150 mg dose.
  • The research involved a parallel-group method at two locations in Japan, with participants' blood samples analyzed for drug concentration over 72 hours and safety monitored for a week.
  • Results showed that drug levels were similarly effective in both groups, and adverse events were minimal, suggesting that renal impairment does not require dosage adjustments in clinical settings.

Article Abstract

Background And Objective: This study measured and compared the exposure and safety of peficitinib (ASP015K), a novel oral Janus kinase inhibitor, in subjects with normal and impaired renal function after a single oral, clinically relevant peficitinib dose.

Methods: This was an open-label, parallel-group study conducted at two centres in Japan. Subjects with normal and mildly, moderately, or severely impaired renal function received a single oral dose of peficitinib (one 150 mg tablet) under fasting conditions in a hospital setting. Blood samples were collected prior to administration and up to 72 h post-dose for pharmacokinetic assessment. Safety was assessed up to 7 days post-dose.

Results: Peficitinib plasma concentration-time profiles were similar between those with normal and impaired renal function. In subjects with impaired renal function, area under the plasma concentration-time curve and maximum concentration were 0.8- to 1.1-fold those in subjects with no impairment. Two subjects (one in the normal group and one in the mildly impaired group) each experienced a treatment-emergent adverse event (TEAE). There were no serious TEAEs, deaths or TEAEs leading to treatment withdrawal.

Conclusions: Peficitinib exposure and TEAEs were similar in subjects with and without renal impairment after a single oral 150 mg dose. Based on these findings, it is not expected that peficitinib dose adjustment will be required in clinical practice, according to the degree of renal impairment. CLINICALTRIALS.

Gov Identifier: NCT02603497.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6989572PMC
http://dx.doi.org/10.1007/s40261-019-00873-7DOI Listing

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