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

NCT01663961 | Completed Phase 1

• 2 other identifiers: 178-CL-0592008-000218-59
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Phase I; Pharmacokinetics; YM178 Oral Controlled Absorption System (OCAS); Digoxin (Lanoxin); DDI (Drug-drug interaction); Open-label; Steady-state; subjects

Outcome Measures

Primary Outcomes (1)

• To determine the effects of steady state YM178 levels on the pharmacokinetics (PK) of a single dose of digoxin

  Cmax (Maximum concentration), AUCinf (Area under the plasma concentration - time curve extrapolated until time = infinity)

  Pre-dose up to 144 hours post-dose

Secondary Outcomes (1)

• To evaluate the interaction between YM178 and digoxin in terms of safety and tolerability through assessment of adverse events, ECG and clinical laboratory assessments

  Baseline to Post study visit (Up to 14 days after last dose)

Study Arms (1)

YM178 OCAS + digoxin

EXPERIMENTAL

Drug: YM178 OCAS; Drug: Digoxin

Interventions

YM178 OCAS DRUG

oral

Also known as: Mirabegron, Myrebtriq

YM178 OCAS + digoxin

Digoxin DRUG

oral

Also known as: Lanoxin

YM178 OCAS + digoxin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (1)

SGS Aster

Paris, 75015, France

Location

MeSH Terms

Interventions

mirabegron; Digoxin

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Clinical Study Manager

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 14, 2012
• Study Start: September 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

FR (1)