- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01514812
A Study to Investigate the Effect of YM150 on the Plasma Concentration of Digoxin in Healthy Subjects
A Double Blind, Randomized, Two Period Crossover Study To Determine The Effect of Multiple Doses of 120 MG Modified Release Formulation of YM150 on the Steady State Pharmacokinetics of Digoxin in Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be of a double blind, randomized, two period crossover design. Two treatments, digoxin in combination with YM150, and digoxin in combination with placebo, will be evaluated. Each subject will receive both treatments in random order. Placebo will be used to maintain the blind. Males and females will be equally divided over the treatment orders.
Subjects will be dosed with digoxin and either YM150 or placebo for 8 days to reach steady state. In the second period the subjects will receive digoxin and the alternate treatment. There will be a washout period of at least 10 days between the consecutive treatments. In both study periods the subjects will be admitted the day prior to study drug administration (Day 0). The subjects will be discharged on Day 10. Approximately one week after the last discharge, the subjects will return to the unit for a post study visit.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Paris, France
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and all tests
- Body weight: male: ≥60 kg, <100 kg; female: ≥45.0 kg, <80.0 kg
- BMI (at screening): ≥18.0, <30.0
Exclusion Criteria:
- Female subjects of child-bearing potential, not practicing adequate methods to prevent pregnancies, like abstinence or double barrier methods
- Known or suspected hypersensitivity / allergy to FXa inhibitors, digoxin, or heart glycosides in general or the constituents of the formulations used
- History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia, including but not limited to neutropenia, thrombocytopenia, thrombocytopathy, thromboasthenia, hemophilia, Von Willebrand's disease, and vascular purpura, bleeding gums, or frequent nose bleeding
- Family history of congenital vascular malformation (e.g. Marfan's Syndrome) and/or bleeding disorder (e.g. hemophilia, Von Willebrand's disease, Christmas disease)
- PT or aPTT at the screening visit outside the normal range
- History of peptic ulcer or of any other organic lesion susceptible to bleed
- Any surgical intervention (including tooth extraction) or trauma within the last 3 months preceding the initiation of the study
- Any clinically significant history of upper gastrointestinal symptoms (such as nausea, vomiting, abdominal discomfort or upset, or heartburn) in the 4 weeks prior to admission to the Research Unit
- Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
- Any of the liver function tests (ALAT, ASAT, LDH and γ-GT) above the upper limit of normal range (ULN)
- Any clinically significant abnormality following the investigator's review of the prestudy physical examination, ECG and clinical laboratory tests
- Abnormal pulse rate and blood pressure measurements at the pre-study visit as follows: Pulse rate <40 or >90 bpm; systolic blood pressure <95 or >160 mmHg; diastolic blood pressure <40 or >95 mmHg (measurements taken after subject has been resting in supine position for 5 min)
- Regular use of any prescribed or OTC (over-the-counter) drugs (including natural and herbal remedies and especially those with P-gp inhibiting activity, like St. John's worth) in the four weeks prior to admission to the Research Unit OR any use of such drugs (including natural and herbal remedies) as well as vitamins in the two weeks prior to admission to the Research Unit
- Donation of blood or blood products within 3 months prior to admission to the Research Unit
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: YM150-placebo sequence group
YM150+digoxin; Washout; Placebo+digoxin
|
oral
oral
oral - modified release formulation of YM150
Other Names:
|
Experimental: placebo-YM150 sequence group
Placebo+digoxin; Washout; YM150+digoxin
|
oral
oral
oral - modified release formulation of YM150
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax of digoxin assessed by its plasma concentration change
Time Frame: for 24 hour after the last dose of each period
|
for 24 hour after the last dose of each period
|
AUC of digoxin assessed by its plasma concentration change
Time Frame: for 24 hour after the last dose of each period
|
for 24 hour after the last dose of each period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in the blood coaggregation indexes such as PT(INR), aPTT and FXa
Time Frame: before dosing and 5hr after dosing on days 4 and 8 and 24h and 48h after the last dose
|
before dosing and 5hr after dosing on days 4 and 8 and 24h and 48h after the last dose
|
Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests
Time Frame: for 10 days after dosing
|
for 10 days after dosing
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150-CL-007
- 2004-004930-15 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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