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
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, see Learn About Clinical Studies.

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 July 29, 2014