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

A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Effect of Mild, Moderate and Severe Renal Impairment on the Pharmacokinetics of YM178

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00750620

Enrollment

Registered

2008-09-10

Start date

2008-09-30

Completion date

2009-09-30

Last updated

2013-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment

Keywords

mild, moderate, and severe renal impaired subjects, normal renal function subjects, Glomerular filtration rate (GFR), Modification of Diet in Renal Disease (MDRD) formula, YM178, pharmacokinetics

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.

Interventions

DRUGYM178

oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Assessment of pharmacokinetics parameters	day 1 - day 6

Secondary

Measure	Time frame
Metabolite analysis	day 1 - day 6
Assessment of safety and tolerability	day 1 - day 6

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026