A Study to Evaluate the Effect of a Single Dose of Digoxin on the Actions in the Bodies of Healthy Subjects After Having Taken Several Doses of YM178

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A study that evaluates the interaction in healthy subjects of the heart drug Digoxin on YM178, when the latter is taken on a continuous basis, in order to establish that there is no risk to patients who may take this combination of drugs.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Europe B.V.
• Treatments: Digoxin; Mirabegron

Criteria

Inclusion Criteria:

• Female subject must be of non-child bearing potential, i.e. post menopausal, surgically sterilized (e.g. tubal ligation), hysterectomy in medical history, or must practice an adequate (double barrier) non-hormonal contraceptive method to prevent pregnancies

• Body Mass Index ≥ 18.5 and < 30 kg/m2

Exclusion Criteria:

• History or presence of cardiac diseases, including arrhythmias (including 1st and 2nd degree atrioventricular heart blocks)

• History of hypokalemia, hypercalcemia or hypomagnesemia

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

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

• Any clinically significant history of gastrointestinal symptoms in the 4 weeks prior to admission to the clinical unit

• 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)

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

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