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

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 |
- Assess pharmacokinetics of mirabegron alone and in combination with rifampin [ Time Frame: One month ]
- Assess safety and tolerability of mirabegron alone and in combination with rifampin [ Time Frame: one month ]

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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:
- 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

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
United States, Florida | |
Miami, Florida, United States, 33126 |
Study Director: | Central Contact | Astellas Pharma Global Development |
Publications:
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00776516 |
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 |
Healthy volunteer subjects CYP3A4 inducer rifampin drug interaction |
pharmacokinetics YM178 mirabegron |
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 |