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Trial record 40 of 226 for:    warfarin AND International

Drug-Drug Interaction Study to Assess the Effects of Multiple-Dose Administration of K-877 on the Pharmacodynamics and the Pharmacokinetics of Multiple-Dose Administration of Warfarin in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT02719431
Recruitment Status : Completed
First Posted : March 25, 2016
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Brief Summary:
The purpose of this study is to assess the effects of K-877 on the pharmacodynamics and the pharmacokinetics of warfarin in healthy adults volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: Warfarin Drug: K-877 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : January 2016
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Warfarin/Warfarin + K-877 Drug: Warfarin
Drug: K-877



Primary Outcome Measures :
  1. International normalized ratio (INR) [ Time Frame: 22 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject provides written informed consent before any study specific evaluation is performed.
  • Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive.
  • Subject has a body mass index of 18 to 30 kg/m², inclusive.

Exclusion Criteria:

  • Subject has clinically relevant abnormalities in the screening or check in assessments.
  • Subject has clinically significant out-of-range PT, INR, activated partial thromboplastin time, fibrinogen, protein C, or protein S.
  • Subject has abnormal prolongation of skin bleeding time at Screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719431


Locations
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United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Kowa Research Institute, Inc.

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Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02719431     History of Changes
Other Study ID Numbers: K-877-108
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Warfarin
Anticoagulants