Study of the Effect of Food on the Pharmacokinetics of Mirabegron

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: NCT00939757
Recruitment Status : Completed
First Posted : July 15, 2009
Last Update Posted : June 26, 2013
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The purpose of this study is to assess the effect of food on the pharmacokinetics of a single oral dose of mirabegron in healthy male and female subjects.

Condition or disease Intervention/treatment Phase
Healthy Pharmacokinetics of Mirabegron Drug: mirabegron Phase 1

Detailed Description:

Subjects will be assigned in a random order to receive 3 dosing regimens:

  1. a single oral dose under a fasting condition;
  2. a single oral dose with food (low fat breakfast);
  3. a single oral dose with food (high fat breakfast).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Open-Label, Randomized, Single Oral Dose, Three-Way Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Mirabegron
Study Start Date : May 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1. mirabegron, lower dose Drug: mirabegron
oral tablet
Other Name: YM178
Experimental: 2. mirabegron, higher dose Drug: mirabegron
oral tablet
Other Name: YM178

Primary Outcome Measures :
  1. Assess the effects of food on the pharmacokinetics of a single oral dose of mirabegron [ Time Frame: 4-5 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The subject must weigh at least 45 kg and have a body mass index (BMI) between 20.0 and 32.0 kg/m2 , inclusive
  • The subject must have a normal or clinically non-significant 12 lead ECG as well as normal or clinically non-significant laboratory test results
  • Female subjects must be post-menopausal (defined as at least 2 years without menses), surgically sterile, or practicing effective contraception, and will continue to use effective contraception during the study period. All females must be non-lactating, and must have a negative pregnancy test result
  • The subject must have negative test results for drugs of abuse and alcohol screens
  • The subject must have good venous access in both arms

Exclusion Criteria:

  • The subject has evidence of QTc interval >430 msec for male, >450 msec for female
  • The subject has liver function test values (ALT, AST, or bilirubin) above the upper limit of normal
  • The subject has a history or presence of psychiatric illness, serious active or recurrent infection, or any medical condition or disorder that precludes the subject from participating in the study
  • The subject has 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
  • The subject has donated or lost ≥ 450 mL blood within 56 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
  • The subject has received or is anticipated to receive a prescription drug within 14 days prior to Day -1 of Period 1 (within 30 days 1 for any long acting treatments such as depot formulations). Subject has taken any over-the-counter (OTC) medications, including complementary and alternative medicines (except for oral contraceptives and occasional use of acetaminophen of up to 2000 mg/day but not more than 4 days per week) within 14 days
  • The subject has consumed alcohol, xanthine derivative-containing food/beverages (tea, chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before admission into the unit
  • The subject has used tobacco-containing products and nicotine-containing products within 6 months
  • The subject consumes more than 5 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week, or has a history of substance abuse, drug addiction, or alcoholism within past 2 years
  • The subject is known to have hepatitis or HIV-1 and/or HIV-2, or is positive for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody

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): NCT00939757

United States, Washington
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma Global Development

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00939757     History of Changes
Other Study ID Numbers: 178-CL-041
First Posted: July 15, 2009    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013

Keywords provided by Astellas Pharma Inc:
Healthy volunteer subjects

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