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Phase I clinical trial to compare the pharmacokinetics and safety of RDN18002 with co-administration of sitagliptin and empagliflozin in healthy adult volunteers

Status Approved

  • First Submitted Date

    2019/09/02

  • Registered Date

    2019/09/10

  • Last Updated Date

    2019/09/09

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004290
    Unique Protocol ID INHAUH 2019-03-006
    Public/Brief Title Phase I clinical trial to compare the pharmacokinetics and safety of RDN18002 with co-administration of sitagliptin and empagliflozin in healthy adult volunteers
    Scientific Title Phase I clinical trial to compare the pharmacokinetics and safety of RDN18002 with co-administration of sitagliptin and empagliflozin in healthy adult volunteers
    Acronym HU-048_P1
    MFDS Regulated Study Yes
    IND/IDE Protocol Yes
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number INHAUH 2019-03-006-001
    Approval Date 2019-04-22
    Institutional Review Board Name Inha University Hospital IRB
    Institutional Review Board Address 27, Inhang-ro, Jung-gu, Incheon
    Institutional Review Board Telephone 032-890-3691
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Sang-Heon Cho
    Title Associate Professor
    Telephone +82-32-890-1122
    Affiliation Inha University Hospital
    Address 27, Inhang-ro, Jung-gu, Incheon, 22332, Rep. of KOREA
    Contact Person for Public Queries
    Name Mi-hwa Ji
    Title CRC
    Telephone +82-32-890-1169
    Affiliation Inha University Hospital
    Address 27, Inhang-ro, Jung-gu, Incheon, 22332, Rep. of KOREA
    Contact Person for Updating Information
    Name Jihye Na
    Title Manager
    Telephone +82-70-7492-5735
    Affiliation Huons
    Address 253, Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13486, Rep. of KOREA
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2019-06-20 Actual
    Target Number of Participant 40
    Primary Completion Date 2019-07-08 , Actual
    Study Completion Date 2019-07-08 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Inha University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2019-06-20 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Huons
    Organization Type Pharmaceutical Company
    Project ID HU-048_P1
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Huons
    Organization Type Pharmaceutical Company
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    1) Purpose: clinical trial to compare the pharmacokinetics and safety of RDN18002 with co-administration of sitagliptin and empagliflozin in healthy adult volunteers
    2) Target disease: type 2 diabetes patients 
    3) End points:
    -PK : AUCt, Cmax of Sitagliptin & Empagliflozin(Primary) / AUCinf, Tmax, t1/2 of Sitagliptin & Empagliflozin(second)
    -Safety : Adverse event, Physical examination, Vital sign, ECG, Clinical laboratory test, Blood sugar test(POCT)
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Phase1
    Intervention Model Cross-over  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Drug  
    Intervention Description
    1. Sequence A : Period 1 R administration -> Period 2 T administration / Wash out : 7 days
    2. Sequence B :  Period 1 T administration -> Period 2 R administration / Wash out : 7 days
    * R(Comparator drug): sitagliptin 1 tablet + empagliflozin 1 tablet, Single oral administration
    * T(Test drug): RDN18002 1 tablet, Single oral administration
    Number of Arms 2
    Arm 1

    Arm Label

    Sequence A

    Target Number of Participant

    20

    Arm Type

    Others

    Arm Description

    1 period: Sitaglitpin 1 tablet + Empagliflozin 1 tablet, Single Oral Administration
    2 period: RDN18002 1 tablet. Single Oral Administration
    * washout period : 7 days
    Arm 2

    Arm Label

    Sequence B

    Target Number of Participant

    20

    Arm Type

    Others

    Arm Description

    1 period: RDN18002 1 tablet. Single Oral Administration
    2 period: Sitaglitpin 1 tablet + Empagliflozin 1 tablet, Single Oral Administration
    * washout period : 7 days
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E11.9)Type 2 diabetes mellitus, without complications 

    Healthy adult
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~45Year

    Description

    1) Healthy adult subject older than 19 to 45 years at the time of screening
    2) Body weight more than 50kg and Body Mass Index(BMI) 18.0kg/m2 ~ 29.0 kg/m2 
    ☞ BMI(kg/m2) = Body weight (kg) / {height (m)}2 
    3) Subject judged to be eligible by Physical examination and interview conducted according to the study protocol. Thus, subject should not have congenital/chronic disease or pathological symptoms/findings 
    4) Subject judged to be eligible by clinical laboratory tests such as hematology test, blood chemistry test, serum electrolyte test, urine test, Urine Microscopy urine test, serology test performed according to the study protocol
    5) Subject who fully understands the clinical trials after in-depth explanation, volunteers to join the clinical trials and signs inform consent
    Exclusion Criteria
    1) Subject with currently or a history of cardiovascular , respiratory, hepatic, renal, neurological, endocrine, hemato-oncology, psychiatric, urinary diseases that is clinically significant 
    2) Subject with a history of pancreatitis
    3) Subject with Type 1 diabetes or diabetic ketoacidosis
    4) Subject with a history of gastrointestinal disorders (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of pharmaceuticals for clinical trials
    5) Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
    6) Subject with with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs including sitagliptin, empagliflozin or other drugs (including aspirin, antibiotics, etc)
    7) Systolic blood pressure ≤100mmHg or ≥ 150mmHg, diastolic blood pressure ≤55mmHg or ≥ 95mmHg at the time of screening
    8) Subject with the following results in the clinical laboratory tests 
    - Aspartate Transaminase(AST) or Alanine Transaminase(ALT) > 2 x upper limit of normal range 
    - Total Bilirubin > 2.0 mg/dl 
    - CK > 2 x upper limit of normal range 
    - eGFR < 60 mL/min/1.73m2 
    9) Subject who takes alcohol > 21 units/week, 1unit=10g=12.5ml of pure alcohol) or can’t stop drinking during the clinical trials 
    10) Subject who smokes> 10 cigarettes/day or can’t stop smoking during the clinical trials 
    11) Subject who have received medication involved in other clinical trials within 6 months before the first administration 
    12) Subject who have donated whole blood donation within 60 days, component blood donation within 30 days or have received blood transfusions before the first administration
    13) Subject taking any ETC or herbal medicine, within 2 weeks or taking any OTC within 1weeks before the first administration (However, if the drug does not affect the pharmacokinetic properties of the clinical trial drug, it may be taken at the discretion of the Investigator.)
    14) Subject taking metabolizing enzyme inducers or inhibitors such as barbitals within 1 month before the first administration
    15) Subject with mental illness or substance abuse
    16) Subject who have consumed food which can significantly change the absorption, distribution, metabolism and excretion of a Investigational drug within 7 days before the first administration (such as grapefruit or its components)
    17) Subject who do not agree with the approved method of contraception during the clinical trial
    * Approved method of contraception: Blockage(condoms, Diaphragm etc.) with other contraception(infertility operation, intrauterine contraceptive device, oral contraceptive pill, hormone, contraceptive cream, jelly or foam etc.)
    18) Subject deemed inappropriate to participate in the clinical trial for clinical laboratory test results or other reasons
    19) Female subject with pregnancy, serum/urine hCG Positive or breast-feeding
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Pharmacokinetics
    Primary Outcome(s) 1
    Outcome
    AUCt of sitagliptin and empagliflozin
    Timepoint
    0, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h after administration
    Primary Outcome(s) 2
    Outcome
    Cmax of of sitagliptin and empagliflozin
    Timepoint
    0, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h after administration
    Secondary Outcome(s) 1
    Outcome
    AUCinf of of sitagliptin and empagliflozin
    Timepoint
    0, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h after administration
    Secondary Outcome(s) 2
    Outcome
    Tmax of of sitagliptin and empagliflozin
    Timepoint
    0, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h after administration
    Secondary Outcome(s) 3
    Outcome
    T1/2 of of sitagliptin and empagliflozin
    Timepoint
    0, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h after administration
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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