A Study to Evaluate the Possible Effects of Taking Mirabegron While Taking a Contraceptive Pill

Healthy Volunteers Clinical Trial

Official title:

A Double-blind Two-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics (PK) of an Ethinyl Estradiol and Levonorgestrel Containing Combined Oral Contraceptive (COC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297179
• Other study ID #: 178-CL-068
• Secondary ID: 2008-000216-32
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2011
• Last updated: July 1, 2013
• Start date: October 2008
• Est. completion date: March 2009

Study information

• Verified date: February 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the effect of multiple doses of mirabegron on the pharmacokinetics of an oral contraceptive.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Subjects above 35 years inclusive are re-evaluated for the risks of using of a COC

• Body Mass Index between 18.5 and 30.0 kg/m2, inclusive

• On oral contraceptive with 30?g ethinyl estradiol (EE) plus either 125?g or 150?g levonorgestrel (LNG) for at least three months prior to date of randomization and well tolerated

• During the study the subject is willing to use 1 of the 3 following contraceptive methods: diaphragm with spermicide, intrauterine device or partner is using condoms in combination with a spermicidal cream

Exclusion Criteria:

Subjects will be excluded from participation if any of the following apply:

• Known or suspected hypersensitivity to YM178 or any components of the formulation used

• Pregnant or breast feeding within 6 months before screening assessment

• Any of the liver function tests (i.e. ALT, AST and Alkaline phosphatase) above the upper limit of normal

• Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active Hay-fever)

• Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator

• Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests

• Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows:

Pulse <40 or >90 bpm; mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90 mmHg (blood pressure 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 occasional use of paracetamol (up to 3 g/day)

• Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit

• Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit

• History of drinking more than 14 units of alcohol per week (1 unit = 270 cc of beer or 40 cc of spirits or 1 glass of wine) within 3 months prior to admission to the Clinical Unit

• Positive test for drugs of abuse or positive alcohol test on the day of admission into 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

• Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study

• Donation of blood or blood products within 3 months prior to admission to the Clinical Unit

• Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2

• Subjects who, in the opinion of the investigator, are not likely to complete the trial for any reason

• Unwillingness to use additional barrier contraceptive methods for the course of the study and for one month after the end of study visit

• Any clinical condition, which, in the opinion of the investigator would not allow safe completion of the study

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers
• Pharmacokinetics of Mirabegron

Intervention

Drug:
• Mirabegron
Oral
• Minidril
Oral
• Placebo
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of pharmacokinetics of Ethinyl estradiol (EE) and Levonorgestrel (LNG) by analysis of blood samples.		Day 21 + Day 29	No
Secondary	Assessment of pharmacokinetics of mirabegron by analysis of blood samples.		Day 21 + Day 49	No

External Links

•   Link to Results on JAPIC