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

Hypertension Clinical Trial

Official title:
A Randomized, Double-Blind, Single-Dose, Placebo- and Positive-Controlled Crossover Study to Evaluate the Effect of Therapeutic and Supratherapeutic Exposure to CS-3150 on QTc Interval Duration in Healthy Male and Female Subjects

Clinical Trial 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.

Clinical Trial Description

This study will assess the effect of therapeutic and supratherapeutic plasma exposures of CS-3150 on the corrected QT (QTc) interval duration after administration of single oral 10-mg and 40-mg doses of CS-3150 in healthy male and female participants. This study will also determine the safety and tolerability of CS-3150 administration, assess the effect on electrocardiogram (ECG) parameters, detect QT interval (QT)/QTc prolongation with a positive control (moxifloxacin), characterize pharmacokinetics (PK) of CS-3150, and assess exposure-response relationship of CS-3150 on QTc. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04019652
Study type Interventional
Source Daiichi Sankyo, Inc.
Contact
Status Completed
Phase Phase 1
Start date November 19, 2015
Completion date December 23, 2015
View Details
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