Comparing the effects of DWP16001 in patients with liver impairment and those with normal liver 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
This study tests how a new medication, DWP16001, works in people with liver problems compared to those with healthy livers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Daewoong Pharmaceutical Co. LTD. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05747664 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetics, pharmacodynamics, safety, and tolerability of DWP16001 in individuals with hepatic impairment compared to those with normal liver function. It is designed as an open-label, multi-center, parallel, single oral dose study. Participants will receive a single dose of the medication, and various assessments will be made to understand how liver function affects the drug's behavior in the body.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 80 with Type 2 Diabetes Mellitus and varying degrees of hepatic function.
Not a fit: Patients with significant gastrointestinal diseases or those with a history of hypersensitivity to related medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective treatment options for patients with Type 2 Diabetes Mellitus who also have liver impairment.
How similar studies have performed: While there have been studies on pharmacokinetics in hepatic impairment, this specific approach with DWP16001 is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Younghee Kim
- Email: 2210285@daewoong.co.kr
- Phone: 82-10-5768-9733
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.