NCT04029090

A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy Subjects

A Randomized, Single-Blind, Placebo-Controlled, Three-Way Crossover Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT/QTc Interval in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effect of MCI-186 on the QT interval corrected for heart rate using Fridericia's formula (QTcF)

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	MCI-186	A single dose of 60 mg MCI-186 over 60 min will be intravenously administered.
DRUG	MCI-186	A single dose of 300 mg MCI-186 over 60 min will be intravenously administered.
DRUG	Placebo	A single dose of 0.9% w/v saline over 60 min will be intravenously administered.

Timeline

• Start date: 2018-09-18
• Primary completion: 2018-10-20
• Completion: 2018-10-23
• First posted: 2019-07-23
• Last updated: 2026-03-17
• Results posted: 2024-11-21

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study