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Drug-Drug Interaction Study 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: NCT02276001
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: K-877 Drug: Cyclosporine 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 : June 2014
Actual Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Maximum concentration (Cmax) [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Area under concentration curve (AUC) [ Time Frame: 72 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): NCT02276001


Locations
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United States, Texas
PPD
Austin, Texas, United States, 75744
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: NCT02276001    
Other Study ID Numbers: K-877-103
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014
Keywords provided by Kowa Research Institute, Inc.:
Adult Volunteers
Additional relevant MeSH terms:
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Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors