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Pharmacokinetic Interaction Study to Assess the Effect of Repeat Doses of Rifampin on Mirabegron (YM178) in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00776516
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : July 3, 2013
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief Summary:
The objective of the study is to assess the PK, safety and tolerability of a single dose of mirabegron alone and in combination with repeat doses of rifampin, a potent CYP3A4 inducer.

Condition or disease Intervention/treatment Phase
Pharmacokinetics of YM178 Drug: mirabegron Drug: rifampin Phase 1

Detailed Description:
A single group of patients will receive both mirabegron alone and in combination with rifampin

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Open-Label, Drug Interaction Study to Evaluate the Effect of Repeat Doses of Rifampin on the Single-Dose Pharmacokinetics of Mirabegron (YM178)
Study Start Date : October 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
mirabegron alone
 Drug: mirabegron
oral
Other Name: YM178
Experimental: 2
mirabegron and rifampin
 Drug: mirabegron
oral
Other Name: YM178

Drug: rifampin
oral
Other Name: Rifadin


Outcome Measures
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Primary Outcome Measures :
  1. Assess pharmacokinetics of mirabegron alone and in combination with rifampin [ Time Frame: One month ]

Secondary Outcome Measures :
  1. Assess safety and tolerability of mirabegron alone and in combination with rifampin [ Time Frame: one month ]

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

Inclusion Criteria:

  • Weighs at least 45 kg and body mass index (BMI) between 18 and 32 kg/m2 at Screening
  • Normal or not clinically significant 12 lead ECG and clinical laboratory test results at Screening
  • Female subjects must be post-menopausal, surgically sterile since at least 1 month prior to screening, or practicing effective non-hormonal contraceptive methods. All females must be non-lactating, and should have a negative result for the pregnancy test at Screening and on Day -1
  • Negative drug and alcohol screens

Exclusion Criteria:

  • Has known or suspected hypersensitivity to mirabegron or rifampin
  • Liver enzyme test abnormalities (ALT, AST, or bilirubin) above the upper limit of normal
  • History or presence of psychiatric illness, serious active or recurrent infection or hepatitis
  • 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 dose of study drug
  • Donation or loss of ≥ 450 mL blood within 56 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
  • Received or is anticipated to receive a prescription drug within 14 days prior to Day -1 or within 30 days prior to Day -1 for any long acting treatments. Use of any over-the-counter medications, including complementary and alternative medicines (except for occasional use of acetaminophen of up to 2000 mg/day but not more than 4 days per week) within 14 days prior to Day -1
  • History of substance abuse within 6 months prior to Screening
  • Current participation in another clinical trial or is taking or has been taking an investigational drug in the 30 days or 10 half lives of the drug, whichever is longer, prior to dosing
  • 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 at Screening
  • Subject has consumed alcohol, caffeine-containing food or beverages, grapefruit juice, grapefruit-containing products or Seville oranges within 48 prior to Day -1
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00776516


Locations
United States, Florida
Miami, Florida, United States, 33126
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma Global Development
More Information
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Additional Information:
Link to Results on JAPIC  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00776516     History of Changes
Other Study ID Numbers: 178-CL-070
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: July 2013

Keywords provided by Astellas Pharma Inc:
Healthy volunteer subjects
CYP3A4 inducer
rifampin
drug interaction
 pharmacokinetics
YM178
mirabegron

Additional relevant MeSH terms:
Rifampin
Mirabegron
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
 Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Urological Agents