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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT00750620

First received: September 8, 2008

Last updated: September 4, 2013

Last verified: September 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Renal Impairment	Drug: YM178	Phase 1


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

Resource links provided by NLM:

Drug Information available for: Mirabegron

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Assessment of pharmacokinetics parameters [ Time Frame: day 1 - day 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Metabolite analysis [ Time Frame: day 1 - day 6 ] [ Designated as safety issue: No ]
Assessment of safety and tolerability [ Time Frame: day 1 - day 6 ] [ Designated as safety issue: No ]


Enrollment:	33
Study Start Date:	September 2008
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1. Severe renal impairment severe renal impairment	Drug: YM178 oral Other Name: mirabegron
Experimental: 2. Moderate renal impairment moderate renal impairment	Drug: YM178 oral Other Name: mirabegron
Experimental: 3. Mild renal impairment mild renal impairment	Drug: YM178 oral Other Name: mirabegron
Experimental: 4. Normal renal function normal renal function	Drug: YM178 oral Other Name: mirabegron

Eligibility


Ages Eligible for Study:	18 Years to 79 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750620

Locations


United States, California

Anaheim, California, United States, 92801
United States, Florida

Miami, Florida, United States, 33014-3616

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Study Director:	Central Contact	Astellas Pharma Global Development

More Information

Additional Information:

Link to Results on JAPIC This link exits the ClinicalTrials.gov site

Publications:

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, Kupčová 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.


Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00750620 History of Changes
Other Study ID Numbers:	178-CL-038
Study First Received:	September 8, 2008
Last Updated:	September 4, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:


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

Additional relevant MeSH terms:


Renal Insufficiency Kidney Diseases Urologic Diseases Mirabegron Adrenergic beta-3 Receptor Agonists Adrenergic beta-Agonists	Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents

ClinicalTrials.gov processed this record on September 23, 2016

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