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

Astellas

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: YM178

Study type: Interventional

Funder types: Industry

Identifiers

NCT00750620

178-CL-038

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

33 participants in 4 patient groups

1. Severe renal impairment

Experimental group

Description:

severe renal impairment

Treatment:

Drug: YM178

2. Moderate renal impairment

Experimental group

Description:

moderate renal impairment

Treatment:

Drug: YM178

3. Mild renal impairment

Experimental group

Description:

mild renal impairment

Treatment:

Drug: YM178

4. Normal renal function

Experimental group

Description:

normal renal function

Treatment:

Drug: YM178