A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: YM178

• Registration Number: NCT00750620
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The objective of this study is to assess and compare the pharmacokinetic properties of YM178 in normal subjects and those with mild, moderate and severe renal impairment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-09
• Study First Posted: 2008-09-10
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• good health other than renal impairment
• body mass index (BMI) between 18 and 40 kg/m2

Exclusion Criteria

• subject with renal impairment has not been on stable dose of concomitant medication for at least 2 weeks
• subject has liver enzyme abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Severe renal impairment	YM178	severe renal impairment
2. Moderate renal impairment	YM178	moderate renal impairment
3. Mild renal impairment	YM178	mild renal impairment
4. Normal renal function	YM178	normal renal function

Primary Outcome Measures

Name	Time	Method
Assessment of pharmacokinetics parameters	day 1 - day 6

Secondary Outcome Measures

Name	Time	Method
Metabolite analysis	day 1 - day 6
Assessment of safety and tolerability	day 1 - day 6