NCT03664544

PK Study in Subjects With Severe Hepatic Impairment

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function.

Conditions

• Severe Hepatic Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	MCI-186	30 mg MCI-186 will be administered intravenously over 60 minutes.

Timeline

• Start date: 2018-11-06
• Primary completion: 2019-03-25
• Completion: 2019-03-25
• First posted: 2018-09-10
• Last updated: 2026-01-08
• Results posted: 2020-04-07

Locations

3 sites across 3 countries: Czechia, Hungary, Slovakia

Regulatory

• FDA-regulated drug study