NCT02256033

Effect of Mild Hepatic Impairment on the Pharmacokinetics of Istradefylline

Effect of Mild Hepatic Impairment (Child-Pugh Class A) on the Single-dose Pharmacokinetics of Istradefylline

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test whether mild liver impairment affects blood levels of istradefylline in humans. Decreased liver function could possibly increase istradefylline levels.

Detailed description

This is a multicenter, open-label, parallel group, single-dose study to determine the single-dose PK of istradefylline in subjects with mild hepatic impairment (HI) (Child-Pugh Class A) and in subjects with normal hepatic function. Ten subjects with mild HI (Child-Pugh Class A) and 10 subjects with normal hepatic function (matched for age, gender, race, and BMI) will be enrolled. Enrollment of the subjects with normal hepatic function will be subsequent to the HI subjects.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Istradefylline	One 40 mg-tablet administered on Day 1

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-10-03
• Last updated: 2024-04-25

Locations

2 sites across 1 country: United States