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

NCT00750620 | Completed Phase 1

• 1 other identifier: 178-CL-038
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Assessment of pharmacokinetics parameters

  day 1 - day 6

Secondary Outcomes (2)

• Metabolite analysis

  day 1 - day 6

• Assessment of safety and tolerability

  day 1 - day 6

Study Arms (4)

1. Severe renal impairment

EXPERIMENTAL

severe renal impairment

Drug: YM178

2. Moderate renal impairment

EXPERIMENTAL

moderate renal impairment

Drug: YM178

3. Mild renal impairment

EXPERIMENTAL

mild renal impairment

Drug: YM178

4. Normal renal function

EXPERIMENTAL

normal renal function

Drug: YM178

Interventions

YM178 DRUG

oral

Also known as: mirabegron

1. Severe renal impairment; 2. Moderate renal impairment; 3. Mild renal impairment; 4. Normal renal function

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• good health other than renal impairment
• body mass index (BMI) between 18 and 40 kg/m2

You may not qualify if:

• subject with renal impairment has not been on stable dose of concomitant medication for at least 2 weeks
• subject has liver enzyme abnormalities

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (2)

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Miami, Florida, 33014-3616, United States

Location

Related 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, Kupcova 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.

  PMID: 23208320 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency; Lymphoma, Follicular

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Central Contact

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 10, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (2)