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NCT00750620 Clinical Trial

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

Renal Impairment Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00750620
Other study ID # 178-CL-038
Secondary ID
Status Completed
Phase Phase 1
First received September 8, 2008
Last updated September 4, 2013
Start date September 2008
Est. completion date September 2009

Study information
Verified date September 2013
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 79 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• YM178
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dickinson J, Lewand M, Sawamoto T, Krauwinkel W, Schaddelee M, Keirns J, Kerbusch V, Moy S, Meijer J, Kowalski D, Morton R, Lasseter K, Riff D, Kupcová V, van Gelderen M. Effect of renal or hepatic impairment on the pharmacokinetics of mirabegron. Clin Drug Investig. 2013 Jan;33(1):11-23. doi: 10.1007/s40261-012-0031-3. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of pharmacokinetics parameters day 1 - day 6 No
Secondary Metabolite analysis day 1 - day 6 No
Secondary Assessment of safety and tolerability day 1 - day 6 No
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