A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects
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ClinicalTrials.gov Identifier: NCT00856570 |
Recruitment Status :
Completed
First Posted : March 5, 2009
Last Update Posted : July 2, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Overactive Bladder Pharmacokinetics | Drug: warfarin Drug: YM178 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

- Drug: warfarin
OralOther Name: Coumadin
- Drug: YM178
OralOther Name: mirabegron
- R- and S-warfarin in plasma: AUCinf, AUClast, Cmax, tmax, t1/2, CL/F [ Time Frame: Day 1-9 and 15-31 ]
- The AUCinf of both enantiomers will be used to assess the potential drug-drug interaction. [ Time Frame: Day 1/2 and 15/16 ]
- Adverse events, clinical laboratory tests (hematology, biochemistry, urinalysis), vital signs, 12-lead ECG, physical examination [ Time Frame: Day -1 - 31 ]
- YM178 in plasma: Ctrough, AUCtau, Cmax, tmax, CL/F [ Time Frame: Day 20-24 ]
- Degree of anticoagulation: AUCPT;0-168h (area under the prothrombin time versus time curve from 0 to 168 h after dosing with warfarin), AUCINR;0-168h, maximum PT (PTmax), time to reach PTmax (tPT; max), INRmax, tINR;max [ Time Frame: Day 1-9 and 23-31 ]

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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:
- Female subject must be of non-child bearing potential, i.e. postmenopausal, surgically sterilized (e.g. tubal ligation), hysterectomy in medical history, or must practice adequate (double barrier) non-hormonal contraceptive methods to prevent pregnancies.
- Body Mass Index (BMI) ≥ 18.5 and < 30 kg/m2, inclusive
Exclusion Criteria:
- Female who is pregnant
- Any of the liver function tests (i.e. alanine aminotransferase (ALT), aspartate aminotransferase (AST) and Alkaline Phosphatase (AP)) above the upper limit of normal (ULN)
- Any clinically significant history of disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator
- Abnormal pulse and/or blood pressure measurements and the pre-study as follows: Pulse < 40 or > 90 bpm; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure > 90 mmHg (blood measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically
- A marked baseline prolongation of QT/QTc interval after repeated measurements of >450 ms, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
- Use of any prescribed or OTC (over-the counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for paracetamol (up to 3 g/day)
- Any use of drugs of abuse within 3 months prior to admission to the clinical unit
- History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit
- History of drinking more than 21 units of alcohol per week (1 unit = 270 ml of beer or 40 ml of spirits or 1 glass of wine) (> 14 units of alcohol for female subjects) within 3 months prior to admission to the clinical unit
- Donation of blood or blood products within 3 months prior to admission to the clinical unit

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): NCT00856570
France | |
Paris, France, 75015 |
Study Chair: | Use Central Contact | Astellas Pharma Europe B.V. |
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00856570 |
Other Study ID Numbers: |
178-CL-040 EudraCT 2008-000211-15 |
First Posted: | March 5, 2009 Key Record Dates |
Last Update Posted: | July 2, 2013 |
Last Verified: | July 2013 |
YM178 Mirabegron DDI |
Phase I Warfarin Pharmacokinetics |
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Warfarin Mirabegron Anticoagulants |
Adrenergic beta-3 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |