Status:
COMPLETED
DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.
Lead Sponsor:
Gannex Pharma Co., Ltd.
Conditions:
Healthy
NAFLD
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to evaluate the effect of itraconazole, a strong inhibitor)of cytochrome P4503A , and phenytoin a strong inducer of cytochrome P450 3A, CYP3A4, CYP1A2 and CYP2C1...
Detailed Description
This multiarm study in HVs and subjects with NAFLD is designed to further characterize the PK, safety and tolerability of ASC41. Part I of the study will assess the effect of itraconazole and phenytoi...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria:
- Part I Healthy subjects between 18 to 55 years of age
- Part II
- Subjects with NAFLD
- Subjects between 18 to 65 years of age
- Key Exclusion criteria:
- Part I
- A history of thyroid disease
- A history of, or current liver disease, or liver injuries
- Platelet count \<150,000/mcL
- INR\> 1.2
- History of, or current electrocardiogram (ECG) abnormalities, arrhythmias or heart valve diseases judged to be clinically significant by the investigator
- Part II
- A history of thyroid disease
- Current or history of cirrhosis or decompensated liver disease
- AST or ALT \> 5X ULN
- DBIL \> ULN
- Acute or chronic liver disease other than NAFLD
- A history of bariatric surgery
- HbA1c \>9.5% at screening
- Testosterone or estrogen replacement therapy
- Inducers or inhibitors of CYP3A4, including herbal therapies such as St John's Wort (CYP3A4 Inducer)
Exclusion
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04845646
Start Date
March 16 2021
End Date
June 10 2021
Last Update
September 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ICON early Phase Services LLC
San Antonio, Texas, United States, 78209