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Drug-Drug Interaction Study in Health 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: NCT02273986
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
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 pharmacokinetics of digoxin in healthy adult volunteers.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : August 2014
Actual Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin

Arm Intervention/treatment
Experimental: Digoxin
Digoxin
Drug: Digoxin
Experimental: Digoxin with K-877
Digoxin with K-877
Drug: Digoxin
Drug: K-877



Primary Outcome Measures :
  1. Maximum concentration (Cmax) [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Area under concentration curve (AUC) [ Time Frame: 24 hours ]


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 is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
  • Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
  • Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.

Exclusion Criteria:

  • Subject has clinically relevant abnormalities in the screening or check in assessments.
  • Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
  • Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.

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): NCT02273986


Locations
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United States, Texas
PPD
Austin, Texas, United States, 78744
Sponsors and Collaborators
Kowa Research Institute, Inc.
Investigators
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Study Director: Stuart Campbell Kowa Research Institute, Inc.

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Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02273986    
Other Study ID Numbers: K-877-106
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014
Keywords provided by Kowa Research Institute, Inc.:
Adult Volunteers
Additional relevant MeSH terms:
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Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs