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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05747664
• Other study ID #: DW_DWP16001110
• Status: Recruiting
• Phase: Phase 1
• Start date: April 13, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2024
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Younghee Kim
• Phone: 82-10-5768-9733
• Email: 2210285[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• DWP16001
0.3mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of DWP16001	Cmax of DWP16001	0 to 48 hours
Primary	AUClast of DWP16001	AUClast of DWP16001	0 to 48 hours