NCT02367872

Phase I Open-label Study to Evaluate Pharmacokinetics of TAK-272 in Participants With Renal or Hepatic Impairment

Phase I Open-label, Parallel-group, Comparative Study to Evaluate the Effects of Renal or Hepatic Impairment on TAK-272 Pharmacokinetics With a Single Oral Administration of TAK-272 in Patients With Renal or Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the effects of renal and hepatic impairment on TAK-272 pharmacokinetics with a single oral administration of TAK-272 in participants with renal or hepatic impairment.

Detailed description

This study is a phase I, open-label, parallel-group, comparative study to evaluate the effects of renal or hepatic impairment on pharmacokinetics of TAK-272 with a single oral administration of TAK-272 in participants with renal or hepatic impairment as compared with participants with normal renal and hepatic function.

Conditions

• Renal Impairment
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	TAK-272	TAK-272 tablet

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-02-20
• Last updated: 2017-11-06
• Results posted: 2017-08-10

Locations

4 sites across 1 country: Japan