Study to Assess the Safety and Plasma Concentration of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers

NCT01720212 | Completed Phase 1

• 1 other identifier: 178-CL-091
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and plasma concentration change of YM178 after single- and repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.

Conditions

Healthy Chinese Volunteers

Keywords

YM178; Mirabegron; OCAS; Chinese Healthy Volunteers; PK; Safety

Outcome Measures

Primary Outcomes (3)

• AUC of YM178 assessed by the plasma concentration changes

  Up to 96 hours after administration

• Cmax of YM178 assessed by the plasma concentration changes

  Up to 96 hours after administration

• t1/2 of YM178 assessed by the plasma concentration changes

  Up to 96 hours after administration

Secondary Outcomes (1)

• Safety assessment of YM178

  Up to 33 days

Study Arms (2)

Single dose group

EXPERIMENTAL

Drug: YM178

Multiple dose group

EXPERIMENTAL

Drug: YM178

Interventions

YM178 DRUG

oral

Also known as: Mirabegron

Multiple dose group; Single dose group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) between 19 and 24, the weight is no less than 50 kg.
• Good health status
• The female subject must be either post-menopausal or surgically sterile. All women of child bearing potential will be required to use adequate contraception, must not be lactating, and must not be breastfeeding.

You may not qualify if:

• The subject who has a known or suspected hypersensitivity to test drug or any of the constituents of the formulation used.
• Drug abusers and alcoholics.
• The subject who has consumed alcohol within 36 hours before administration.
• The subject who is positive for hepatitis B surface antigen (HBs- Ag) or hepatitis C virus (HCV) antibody.
• The subject who is positive for human immunodeficiency virus (HIV).
• The subject who consumes more than 1L tea and coffee per day.
• Smokers.
• The subject who has donated or lost over 200 mL blood
• The subject who has participated in other clinical trials
• The subject who has taken other drugs that prototype and its main metabolites had not completely eliminated
• The subject who has taken drugs repeatedly that may affect the metabolism of the test drug
• Psychopath.

Sponsors & Collaborators

• Astellas Pharma China, Inc.: lead

Study Sites (1)

Unknown Facility

Shanghai, China

Location

MeSH Terms

Interventions

mirabegron

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 2, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 2, 2012

Record last verified: 2012-10

Locations

CN (1)