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
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 Digoxin in Healthy Subjects|
- To determine the effects of steady state YM178 levels on the pharmacokinetics (PK) of a single dose of digoxin [ Time Frame: Pre-dose up to 144 hours post-dose ] [ Designated as safety issue: No ]Cmax (Maximum concentration), AUCinf (Area under the plasma concentration - time curve extrapolated until time = infinity)
- To evaluate the interaction between YM178 and digoxin in terms of safety and tolerability through assessment of adverse events, ECG and clinical laboratory assessments [ Time Frame: Baseline to Post study visit (Up to 14 days after last dose) ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
|Experimental: YM178 OCAS + digoxin||
Drug: YM178 OCAS
Other Names:Drug: Digoxin
Other Name: Lanoxin
Subjects receive a single oral dose of digoxin on Day 1. A full pharmacokinetic profile of digoxin is obtained for up to 144 hours post-dose. On the morning of Day 7, after the scheduled assessments are done, the subjects leave the clinic and return on Day 9.
From Day 10 up to and including Day 23, subjects receive daily oral doses of YM178 q.d. A single dose of digoxin is given in combination with YM178 on Day 18 (8 days after the first dose of YM178). On this day, a complete pharmacokinetic profile for digoxin is obtained up to 144 hours post-dose.
From Day 16 up to and including Day 19, blood samples for bioanalysis of YM178 are taken regularly. In addition, vital signs, safety ECG (Electrocardiogram) measurements, safety laboratory assessments, adverse events and concomitant medications are monitored throughout the investigational period.
Subjects return for a Post Study Visit 7-14 days after the last dosing occasion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663961
|Paris, France, 75015|
|Study Chair:||Clinical Study Manager||Astellas Pharma Europe B.V.|