Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Dose of Miridesap in Healthy Japanese Subjects. Issue 5 (17th December 2018)

• Record Type: Journal Article
• Authors: Ino, Hiroko; Doi, Yohei; Liefaard, Lia; Cookson, Louise; Chen, Chao; Itoh, Hiroshi; Igarashi, Harue; Nakano, Atsushi
• Is Part Of: Clinical pharmacology in drug development. Volume 8:Issue 5(2019)
• Page Start: 612
• Page End: 618
• Publication Date: 2018-12-17
• Subjects: pharmacodynamics -- pharmacokinetics -- serum amyloid P component -- systemic amyloidosis -- tolerability; Drugs -- Testing -- Periodicals; Drug development -- Periodicals; Clinical pharmacology -- Periodicals; 615.580724
• DOI: 10.1002/cpdd.631
• Languages: English
• ISSNs: 2160-7648

Abstract

Abstract: 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.