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Completed

NCT Number: NCT01720212

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

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

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Key information

Conditions

Healthy Chinese Volunteers

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

YM178

Drug

oral

Other names: Mirabegron

Primary outcomes

  1. AUC of YM178 assessed by the plasma concentration changes

    Time frame: Up to 96 hours after administration

  2. Cmax of YM178 assessed by the plasma concentration changes

    Time frame: Up to 96 hours after administration

  3. t1/2 of YM178 assessed by the plasma concentration changes

    Time frame: Up to 96 hours after administration

Secondary outcomes

  1. Safety assessment of YM178

    Time frame: Up to 33 days

    Safety is to be assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs

Sponsors and collaborators

Lead sponsor

Astellas Pharma China, Inc.

Industry

Registry information

Official study title

An Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 2, 2012
Registry last updated
Nov 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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