Changes in Cardiac Function After a Single Intrave

Authors: SangIn Park JaeWoo Kim KyungSang Yu InJin Jang SeungHwan Lee

Publish Date: 2017/02/03

Volume: 37, Issue: 4, Pages: 393-403

PDF Link

Abstract

A doseblockrandomized doubleblind placebocontrolled singledose escalation study was conducted in 44 healthy subjects receiving 20 40 80 160 240 or 320 μg/kg CKD712 or placebo Pharmacodynamics were evaluated using computerized impedance cardiography vital signs platelet aggregation and bleeding time Serial blood and urine samples for pharmacokinetic analysis were collected up to 12 and 24 h respectively after the initiation of intravenous drug infusion Tolerability assessments were performed throughout the studyThe area under the effect–time curve of the cardiac index AUECCI and systolic blood pressure AUECSBP changed significantly with the 160 and 320 µg/kg doses of CKD712 compared with placebo Furthermore the AUECCI and AUECSBP tended to increase as the systemic exposure of CKD712 increased from 20 to 240 µg/kg The frequency of drugrelated adverse events AEs including cardiovascular symptoms was higher with the 320 µg/kg doseAll procedures in this study were performed in accordance with the recommendations of the Declaration of Helsinki 1964 on biomedical research involving human subjects This study was approved by the IRB at SNUH Seoul Republic of Korea IRB number H0508536156

Keywords: