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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Younghee Kim
2210285@daewoong.co.kr
82-10-5768-9733
Time Frame
Start Date: 2023-04-13
Estimated Completion Date: 2024-04-30
Participants
Target number of participants: 24
Treatments
Experimental: DWP16001 to normal haptic function
Normal hepatic function
Experimental: DWP16001 to Child-Pugh Class A
Child-Pugh Class A
Experimental: DWP16001 to Child-Pugh Class B
Child-Pugh Class B
Related Therapeutic Areas
Sponsors
Leads: Daewoong Pharmaceutical Co. LTD.