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

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05747664
Collaborator
(none)
24
Enrollment
3
Arms
10.1
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The study design is An open-label, multi-center, parallel, single oral dose study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Feb 28, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: DWP16001 to normal haptic function

Normal hepatic function

Drug: DWP16001
0.3mg
Other Names:
  • DWP16001 0.3mg

    		•
    Experimental: DWP16001 to Child-Pugh Class A

    Child-Pugh Class A

    Drug: DWP16001
    0.3mg
    Other Names:
  • DWP16001 0.3mg

    		•
    Experimental: DWP16001 to Child-Pugh Class B

    Child-Pugh Class B

    Drug: DWP16001
    0.3mg
    Other Names:
  • DWP16001 0.3mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cmax of DWP16001 [0 to 48 hours]

      Cmax of DWP16001

    2. AUClast of DWP16001 [0 to 48 hours]

      AUClast of DWP16001

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. 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.

    2. A person who is 19 years of age or more and under 80 years of age at the time of screening.

    3. 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:

    1. 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.

    2. 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.

    3. Serum Cr >1.5mg/dL or eGFR (CKD-EPI Cr) <60mL/min/1.73m2

    4. Those who have used SGLT2 inhibitor family drugs within two weeks of the scheduled date of administration of DWP16001.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Daewoong Pharmaceutical Co. LTD.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daewoong Pharmaceutical Co. LTD.
    ClinicalTrials.gov Identifier:
    NCT05747664
    Other Study ID Numbers:
    • DW_DWP16001110
    First Posted:
    Feb 28, 2023
    Last Update Posted:
    Feb 28, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Feb 28, 2023