Study of the Effect of Food on the Pharmacokinetics of Mirabegron

June 24, 2013 updated by: Astellas Pharma Inc

A Phase 1, Open-Label, Randomized, Single Oral Dose, Three-Way Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Mirabegron

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Enrollment (Actual)

76

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Tacoma, Washington, United States, 98418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. mirabegron, lower dose
oral tablet
Other Names:
  • YM178
Experimental: 2. mirabegron, higher dose
oral tablet
Other Names:
  • YM178

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the effects of food on the pharmacokinetics of a single oral dose of mirabegron
Time Frame: 4-5 weeks
4-5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

July 13, 2009

First Submitted That Met QC Criteria

July 14, 2009

First Posted (Estimate)

July 15, 2009

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 24, 2013

Last Verified

June 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on mirabegron

3
Subscribe