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
NCT04029090 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2026-05-22
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
- 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
-
A single dose of 0.9% w/v saline over 60 min will be intravenously administered.
Sponsors & Collaborators
-
Tanabe Pharma Corporation
lead INDUSTRY
Principal Investigators
-
General Manager · Tanabe Pharma Corporation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-09-18
- Primary Completion
- 2018-10-20
- Completion
- 2018-10-23
- FDA Drug
- Yes
Countries
- Japan
Study Locations
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