NCT04019652

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hypertension
• Mineralocorticoid Receptor Antagonist

Interventions

Type	Name	Description
DRUG	CS-3150	Single, oral administration; 10-mg or 40-mg dose
DRUG	Moxifloxacin	Single, oral administration; 400 mg-tablet
DRUG	Placebo matching moxifloxacin tablet	Placebo tablets matching moxifloxacin tablets
DRUG	Placebo matching CS-3150	Placebo tablets matching CS-3150 tablets

Timeline

• Start date: 2015-11-19
• Primary completion: 2015-12-23
• Completion: 2015-12-23
• First posted: 2019-07-15
• Last updated: 2019-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study