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

Astellas Pharma Inc33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Renal Impairment

Interventions

YM178DRUG

oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Anaheim, California, United States

Unnamed facility

Miami, Florida, United States

Outcomes

Primary Outcomes

Assessment of pharmacokinetics parameters

Time frame: day 1 - day 6

Secondary Outcomes

Metabolite analysis

Time frame: day 1 - day 6

Assessment of safety and tolerability

Time frame: day 1 - day 6

Data from ClinicalTrials.gov

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