Study of the Effect of Food on the Pharmacokinetics of Mirabegron

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00939757
First received: July 13, 2009
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Healthy
Pharmacokinetics of Mirabegron
Drug: mirabegron
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, Randomized, Single Oral Dose, Three-Way Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Mirabegron

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Assess the effects of food on the pharmacokinetics of a single oral dose of mirabegron [ Time Frame: 4-5 weeks ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. mirabegron, lower dose Drug: mirabegron
oral tablet
Other Name: YM178
Experimental: 2. mirabegron, higher dose Drug: mirabegron
oral tablet
Other Name: YM178

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).
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939757

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

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00939757     History of Changes
Other Study ID Numbers: 178-CL-041
Study First Received: July 13, 2009
Last Updated: June 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Healthy volunteer subjects
pharmacokinetics
YM178
mirabegron
food

ClinicalTrials.gov processed this record on April 15, 2014