The Effect of CS-3150 Exposure on Corrected QT (QTc) Interval Duration in Healthy Volunteers

NCT04019652 ↗

Phase 1 Completed 55 enrolled Daiichi Sankyo

RandomizedCrossoverDouble-blindPrevention

Summary

This study will test if a study drug (CS-3150) will affect the heart rate in healthy males and females. Two doses of the study drug will be tested. Heart rate is not expected to be different between the study groups.

Timeline

Start: 2015-11-19
Primary completion: 2015-12-23
Completion: 2015-12-23

Outcome

Met primary endpoint

paper The upper 90%CI limits of ∆∆QTcF were ≤0 milliseconds at all times for both doses of esaxerenone. PMID 32255542 ↗

Publications

Mendell J, Kobayashi F, Shimizu T. Randomized, Double-Blind, Single-Dose, Placebo-Controlled Crossover Study to Evaluate the Effects of Esaxerenone on QTc Interval in Healthy Subjects. Clin Pharmacol Drug Dev. 2020 Aug;9(6):709-718. doi: 10.1002/cpdd.794. Epub 2020 Apr 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CS-3150	Unknown	10 mg	Oral
Subject	CS-3150	Unknown	40 mg	Oral
Subject	Moxifloxacin	Small molecule	400 mg	Oral