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PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients

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: NCT02214693
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Brief Summary:
This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: DA-1229 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Tolerability of DA-1229(Evogliptin) Tablet in Renal Impaired Patients
Study Start Date : July 2014
Actual Primary Completion Date : March 2015

Arm Intervention/treatment
Experimental: Group 1(Severe decrease in GFR)
Severe decrease in GFR
Drug: DA-1229
Other Name: Evogliptin

Experimental: Group 2(Moderate decrease in GFR)
Moderate decrease in GFR
Drug: DA-1229
Other Name: Evogliptin

Experimental: Group 3(Mild decrease in GFR)
Mild decrease in GFR
Drug: DA-1229
Other Name: Evogliptin

Experimental: Group 4(Normal GFR)
Normal GFR
Drug: DA-1229
Other Name: Evogliptin




Primary Outcome Measures :
  1. Area Under Curve(AUC) last [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 20 and 70
  • Weights between 50 and 90kg(Female : 40 and 90kg)
  • Volunteer who totally understands the progress of this clinical trials, makes decision by his free will, and signed a consent form to follow the progress
  • Stable results of estimated GFR in 4 months recently

Exclusion Criteria:

  • Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
  • Volunteer who had drug(DPP-4 inhibitor) hypersensitivity reaction
  • Volunteer who already participated in other trials in 2 months
  • Volunteer who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

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): NCT02214693


Locations
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Korea, Republic of
Clinical Trial Center, Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.

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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02214693    
Other Study ID Numbers: DA1229_RI_I
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015
Keywords provided by Dong-A ST Co., Ltd.:
patients
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases