Status:

COMPLETED

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

Lead Sponsor:

Astellas Pharma Inc

Conditions:

Renal Impairment

Eligibility:

All Genders

18-79 years

Phase:

PHASE1

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.

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

September 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2009

Estimated Enrollment :

33 Patients enrolled

Trial Details

Trial ID

NCT00750620

Start Date

September 1 2008

End Date

September 1 2009

Last Update

September 5 2013

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Anaheim, California, United States, 92801

2

Miami, Florida, United States, 33014-3616

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