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Drug-Drug Interaction Study to Assess the Effects of Multi Dose Clopidogrel on the Pharmacokinetics of Single-Dose K-877 in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922465
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Brief Summary:
The primary objective of this study is to assess the effects of clopidogrel on the PK of K-877 in healthy adult subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: K-877 Drug: Clopidogrel 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 : September 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: K-877 & Clopidogrel
K-877 & Clopidogrel orally
Drug: K-877
Drug: Clopidogrel



Primary Outcome Measures :
  1. Plasma exposure of K-877 by measuring Cmax when administered alone or with Clopidogrel [ Time Frame: Up to 72 hours after dosing ]
  2. Plasma exposure of K-877 by measuring AUC when administered alone or with Clopidogrel [ Time Frame: Up to 72 hours after dosing ]

Secondary Outcome Measures :
  1. Evaluation of 20 participants with treatment emergent adverse events as assessed by the principle investigator [ Time Frame: Through study completion up to 17 days. ]
    Subjects will be questioned in a general way by the investigator without specific symptoms suggested.



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 at screening;
  • Subject has a BMI of 18 to 30 kg/m², inclusive;
  • Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges, or results that do not show clinically significant abnormalities, as judged by the Investigator at screening and check-in;

Exclusion Criteria:

  • Subject is a woman who is pregnant or breastfeeding;
  • Subject has clinically significant abnormalities in the screening or check-in assessments;
  • Subject has current or history of clinically significant coagulation, bleeding, or platelet disorders;
  • Subject or a family member of the subject has a history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations, including aneurysms;

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): NCT02922465


Locations
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United States, Ohio
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Kowa Research Institute, Inc.

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Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02922465    
Other Study ID Numbers: K-877-109
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs