To Compare the Safety and PK/PD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function
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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 diabetes-mellitus-type-2
Started Apr 2023
Typical duration for phase_1 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2023
CompletedFirst Posted
Study publicly available on registry
February 28, 2023
CompletedStudy Start
First participant enrolled
April 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedApril 8, 2024
April 1, 2024
1 year
February 8, 2023
April 5, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Cmax of DWP16001
Cmax of DWP16001
0 to 48 hours
AUClast of DWP16001
AUClast of DWP16001
0 to 48 hours
Study Arms (3)
DWP16001 to normal haptic function
EXPERIMENTALNormal hepatic function
DWP16001 to Child-Pugh Class A
EXPERIMENTALChild-Pugh Class A
DWP16001 to Child-Pugh Class B
EXPERIMENTALChild-Pugh Class B
Interventions
0.3mg
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2023
First Posted
February 28, 2023
Study Start
April 13, 2023
Primary Completion
April 30, 2024
Study Completion
April 30, 2024
Last Updated
April 8, 2024
Record last verified: 2024-04