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A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01334905
First received: April 12, 2011
Last updated: October 10, 2011
Last verified: October 2011
History of Changes
  Purpose

The purpose of the study is to evaluate safety of YM178 and the effect of food intake on the pharmacokinetics of YM178 in healthy adult subjects.


Condition Intervention Phase
Healthy Volunteer
Pharmacokinetics of YM178
 Drug: YM178
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase 1, Open-Label, Single Oral Dose Study to Assess the Safety, Pharmacokinetics and Effect of Food on the Pharmacokinetics of Mirabegron (YM178) in Healthy Volunteers

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:
  • Maximum plasma concentration (Cmax) of YM178 [ Time Frame: Up to 96 hrs post dose ] [ Designated as safety issue: No ]
  • AUC (area under the curve) of YM178 plasma concentration [ Time Frame: Up to 96 hrs post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tmax of YM178 plasma concentration [ Time Frame: Up to 96 hrs post dose ] [ Designated as safety issue: No ]
  • t1/2 of YM178 plasma concentration [ Time Frame: Up to 96 hrs post dose ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam. [ Time Frame: Up to 96 hrs post dose ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A group
fasted condition then fed condition
 Drug: YM178
oral
Other Name: mirabegron
Experimental: Part B group
fed condition then fasted condition
 Drug: YM178
oral
Other Name: mirabegron

Detailed Description:

A open-label, randomized, crossover study to assess the effect of food on the pharmacokinetics of single dose of YM178 administered under fasted and fed conditions.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A normal or clinically non-significant 12 lead ECG as well as normal or clinically non-significant laboratory test results at the time of Screening
  • Body weigh at least 50 kg in male and 45 kg in female and body mass index (BMI) between 18.5 and 26.9 kg/m2
  • All women of child bearing potential are required to use adequate contraception consisting of two forms of birth control

Exclusion Criteria:

  • Hypersensitivity to YM178 or other beta-3 agonists or any of the constituents of the formulation used
  • Liver function test values above the upper limit of normal
  • A history or presence of psychiatric illness, serious active or recurrent infection
  • A previous history of cancer other than basal cell carcinoma or Stage 1 squamous cell carcinoma that has not been in remission for at least 5 years prior to the study
  • Donated or lost ≥ 500 mL blood within 3 months or donated plasma within 2 weeks prior to the study
  • Receiving or being anticipated to receive a prescription drug or OTC medications within 14 days prior to the study
  • Consuming alcohol, xanthine derivative-containing food/beverages (tea, chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before the study
  • A history of substance abuse, drug addiction, or alcoholism within past 2 years prior to the study
  • currently participating in another clinical trial or taking or has been taking an investigational drug at least 60 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334905

Locations
Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01334905     History of Changes
Other Study ID Numbers: 178-CL-092
Study First Received: April 12, 2011
Last Updated: October 10, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Astellas Pharma Inc:
Overactive Bladder
Urinary incontinence
YM178
mirabegron
Food effect

ClinicalTrials.gov processed this record on May 23, 2013