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Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Dose of Miridesap in Healthy Japanese Subjects
Author(s) -
Ino Hiroko,
Doi Yohei,
Liefaard Lia,
Cookson Louise,
Chen Chao,
Itoh Hiroshi,
Igarashi Harue,
Nakano Atsushi
Publication year - 2019
Publication title -
clinical pharmacology in drug development
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.711
H-Index - 22
eISSN - 2160-7648
pISSN - 2160-763X
DOI - 10.1002/cpdd.631
Subject(s) - tolerability , medicine , pharmacokinetics , pharmacodynamics , adverse effect , placebo , pharmacology , cohort , anesthesia , vital signs , pathology , alternative medicine
This phase 1 study characterized the safety, tolerability, pharmacokinetics, and pharmacodynamics of miridesap (GSK2315698) following an intravenous (IV) infusion in healthy Japanese men. Subjects in Cohort 1 received 1‐hour IV infusions of 10, 20, and 40 mg of miridesap or placebo, and subjects in Cohort 2 received a 15‐hour IV infusion of 20 mg/h of miridesap or placebo. No treatment‐related adverse events were reported. No new safety signals were identified for either vital signs or clinical laboratory parameters. A dose‐dependent increase was observed in miridesap exposure (area under the concentration‐time curve and maximum observed drug concentration) in the 10 to 40 mg/h dose range after a 1‐hour IV infusion of miridesap. Rapid depletion of circulating serum amyloid P component was observed after the initiation of miridesap infusion. Serum amyloid P component concentrations fell in a dose‐dependent manner following administration of miridesap.