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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01334905
Recruitment Status : Completed
First Posted : April 13, 2011
Last Update Posted : June 12, 2013
Astellas Pharma Taiwan, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteer Pharmacokinetics of YM178 Drug: YM178 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : March 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron

Arm Intervention/treatment
Experimental: Part A group
fasted condition then fed condition
Drug: YM178
Other Name: mirabegron

Experimental: Part B group
fed condition then fasted condition
Drug: YM178
Other Name: mirabegron

Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) of YM178 [ Time Frame: Up to 96 hrs post dose ]
  2. AUC (area under the curve) of YM178 plasma concentration [ Time Frame: Up to 96 hrs post dose ]

Secondary Outcome Measures :
  1. tmax of YM178 plasma concentration [ Time Frame: Up to 96 hrs post dose ]
  2. t1/2 of YM178 plasma concentration [ Time Frame: Up to 96 hrs post dose ]
  3. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01334905

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

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01334905     History of Changes
Other Study ID Numbers: 178-CL-092
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: October 2011

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

Additional relevant MeSH terms:
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