Pharmacokinetics, Pharmacodynamics, and Safety of the Novel Calcimimetic Agent Evocalcet in Healthy Japanese Subjects: First-in-Human Phase I Study.

ABSTRACT:

Background and objectives

Evocalcet is a novel calcimimetic agent with potential to improve the treatment of secondary hyperparathyroidism in patients with chronic kidney disease. This study aimed to determine the pharmacokinetics, pharmacodynamics, and safety of evocalcet in healthy Japanese subjects.

Methods

This was a single-blind, placebo-controlled, single-dose study and an 8-day multiple-dose study of evocalcet (MT-4580/KHK7580) in 66 healthy Japanese subjects.

Results

After a single dose of evocalcet 1-20 mg, the time to maximum plasma concentration was attained in 1.5-2 h (median), and the elimination half-life was 12.98-19.77 h (mean). Within this dose range, the maximum plasma concentration and area under plasma concentration-time curve increased dose propor

SUBMITTER: Akizawa T 

PROVIDER: S-EPMC6182462 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature