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To Compare the Safety and PK/PD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function

Primary Purpose

Diabetes Mellitus, Type 2

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
DWP16001
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: A person who has decided to participate voluntarily and agreed in writing prior to the screening procedure after understanding the detailed explanation of this clinical trial. A person who is 19 years of age or more and under 80 years of age at the time of screening. Those with a weight of 45.0 kg or more and 90.0 kg or less and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less. Exclusion Criteria: A person who has a history of gastrointestinal diseases (e.g., ulcer, inflammatory bowel disease, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of DWP16001. Those who are hypersensitive to drugs and other drugs (aspirin, antibiotics, etc.) including the SGLT2 inhibitor family or who have a history of clinically significant hypersensitivity reaction. Serum Cr >1.5mg/dL or eGFR (CKD-EPI Cr) <60mL/min/1.73m2 Those who have used SGLT2 inhibitor family drugs within two weeks of the scheduled date of administration of DWP16001.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    DWP16001 to normal haptic function

    DWP16001 to Child-Pugh Class A

    DWP16001 to Child-Pugh Class B

    Arm Description

    Normal hepatic function

    Child-Pugh Class A

    Child-Pugh Class B

    Outcomes

    Primary Outcome Measures

    Cmax of DWP16001
    Cmax of DWP16001
    AUClast of DWP16001
    AUClast of DWP16001

    Secondary Outcome Measures

    Full Information

    First Posted
    February 8, 2023
    Last Updated
    February 17, 2023
    Sponsor
    Daewoong Pharmaceutical Co. LTD.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05747664
    Brief Title
    To Compare the Safety and PK/PD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function
    Official Title
    An Open-label, Multi-center, Parallel, Single Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of DWP16001 in Subjects With Hepatic Impairment Compared With Subjects With Normal Hepatic Function
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 28, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Daewoong Pharmaceutical Co. LTD.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of DWP16001 in subjects with hepatic impairment compared with subjects with normal hepatic function.
    Detailed Description
    The study design is An open-label, multi-center, parallel, single oral dose study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DWP16001 to normal haptic function
    Arm Type
    Experimental
    Arm Description
    Normal hepatic function
    Arm Title
    DWP16001 to Child-Pugh Class A
    Arm Type
    Experimental
    Arm Description
    Child-Pugh Class A
    Arm Title
    DWP16001 to Child-Pugh Class B
    Arm Type
    Experimental
    Arm Description
    Child-Pugh Class B
    Intervention Type
    Drug
    Intervention Name(s)
    DWP16001
    Other Intervention Name(s)
    DWP16001 0.3mg
    Intervention Description
    0.3mg
    Primary Outcome Measure Information:
    Title
    Cmax of DWP16001
    Description
    Cmax of DWP16001
    Time Frame
    0 to 48 hours
    Title
    AUClast of DWP16001
    Description
    AUClast of DWP16001
    Time Frame
    0 to 48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: A person who has decided to participate voluntarily and agreed in writing prior to the screening procedure after understanding the detailed explanation of this clinical trial. A person who is 19 years of age or more and under 80 years of age at the time of screening. Those with a weight of 45.0 kg or more and 90.0 kg or less and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less. Exclusion Criteria: A person who has a history of gastrointestinal diseases (e.g., ulcer, inflammatory bowel disease, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of DWP16001. Those who are hypersensitive to drugs and other drugs (aspirin, antibiotics, etc.) including the SGLT2 inhibitor family or who have a history of clinically significant hypersensitivity reaction. Serum Cr >1.5mg/dL or eGFR (CKD-EPI Cr) <60mL/min/1.73m2 Those who have used SGLT2 inhibitor family drugs within two weeks of the scheduled date of administration of DWP16001.

    12. IPD Sharing Statement

    Learn more about this trial

    To Compare the Safety and PK/PD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function

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