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

NCT05747664 — Phase 1, Unknown, 24 participants, Daewoong Pharmaceutical Co. LTD.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT05747664
Status	Unknown
Phase	Phase 1
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	24 (Estimated)
Sponsor	Daewoong Pharmaceutical Co. LTD. (Industry)
Conditions	Diabetes Mellitus, Type 2
Interventions	DWP16001 (Drug)
Dates	start 2023-04-13, primary completion 2024-04-30 (estimated), completion 2024-04-30 (estimated), first posted 2023-02-28, last updated 2024-04-08
Locations	1 site in South Korea

-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.

Expand all sections · Collapse all

+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
DWP16001 to normal haptic function	Experimental	Drug: DWP16001	Normal hepatic function
DWP16001 to Child-Pugh Class A	Experimental	Drug: DWP16001	Child-Pugh Class A
DWP16001 to Child-Pugh Class B	Experimental	Drug: DWP16001	Child-Pugh Class B

DWP16001 (Drug), also known as DWP16001 0.3mg: 0.3mg

+Outcome measures

Primary outcomes

Cmax of DWP16001 [0 to 48 hours]: Cmax of DWP16001
AUClast of DWP16001 [0 to 48 hours]: AUClast of DWP16001

+Eligibility

Sex: All, ages: 19 Years to 80 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Seoul National University Hospital	Seoul	South Korea	Recruiting