Back to resultsDDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.
Primary Purpose
Healthy, NAFLD
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ASC41
Itraconazole
Phenytoin
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Healthy, NAFLD, DDI (Drug-Drug Interaction), Itraconazole, Phenytoin, THR beta agonist, ASC41
Eligibility Criteria
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)
Sites / Locations
- ICON early Phase Services LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
ASC41 + Itraconazole group
ASC41 + Phenytoin group
ASC41 group
Arm Description
ASC41 5 mg po, One 5 mg ASC41 tablet on day 1 and 11. Itraconazole oral capsule 200 mg po qd (2 capsules given 1x/day or 200 mg/day) on days 6-16.
ASC41 5 mg po, One 5 mg ASC41 tablet on day 1 and 19. Phenytoin oral capsule 300 mg (100 mg 3 x/day) on days 6-19.
(1) ASC41 5 mg po. One 5 mg ASC41 tablet on day 1.
Outcomes
Primary Outcome Measures
AUC of ASC41
Evaluate the Area under the plasma concentration versus time curve.
Cmax of ASC41
Evaluate the Peak Plasma Concentration.
Secondary Outcome Measures
t1/2 of ASC41
Evaluate the Terminal-Phase Half-Life.
CL/F of ASC41
Evaluate the Apparent Systemic Clearance.
Vd/F of ASC41
Evaluate the Apparent Volume of Distribution.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 24 days.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04845646
Brief Title
DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.
Official Title
Phase I Open Label, Drug-Drug Interaction, Study to Evaluate the Effect of Itraconazole and Phenytoin on the Pharmacokinetics of ASC41 in Healthy Volunteers and A Study to Evaluate the PK, Safety and Tolerability in Subjects With Non-alcoholic Fatty Liver Disease (NAFLD).
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
June 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gannex Pharma Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 CYP2C19 on the pharmacokinetics of ASC41, a THR beta agonist tables in healthy subjects. The PK, Safety and Tolerability of ASC 41 in Subjects with NAFLD will also be evaluated. Approximately 24 subjects including 16 healthy volunteers (HVs) and 8 subjects with NAFLD will be enrolled. This study consists of 3 cohorts.
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 phenytoin on the single-dose PK of ASC41 in HVs. Part II of the study will evaluate the PK, safety and tolerability of a single dose of ASC41 in subjects with NAFLD. The pharmacokinetics of ASC41 and its metabolite ASC41-A will be assessed in both parts I and II. The secondary objective of the study is to characterize the safety and tolerability of oral ASC41 in subjects in the U.S. with NAFLD and in HVs. Approximately 24 male and female participants will be enrolled. This study consists of 3 cohorts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, NAFLD
Keywords
Healthy, NAFLD, DDI (Drug-Drug Interaction), Itraconazole, Phenytoin, THR beta agonist, ASC41
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASC41 + Itraconazole group
Arm Type
Experimental
Arm Description
ASC41 5 mg po, One 5 mg ASC41 tablet on day 1 and 11.
Itraconazole oral capsule 200 mg po qd (2 capsules given 1x/day or 200 mg/day) on days 6-16.
Arm Title
ASC41 + Phenytoin group
Arm Type
Experimental
Arm Description
ASC41 5 mg po, One 5 mg ASC41 tablet on day 1 and 19.
Phenytoin oral capsule 300 mg (100 mg 3 x/day) on days 6-19.
Arm Title
ASC41 group
Arm Type
Experimental
Arm Description
(1) ASC41 5 mg po. One 5 mg ASC41 tablet on day 1.
Intervention Type
Drug
Intervention Name(s)
ASC41
Intervention Description
5mg/tablet
Intervention Type
Drug
Intervention Name(s)
Itraconazole
Intervention Description
200mg/capsule
Intervention Type
Drug
Intervention Name(s)
Phenytoin
Intervention Description
300mg/capsule
Primary Outcome Measure Information:
Title
AUC of ASC41
Description
Evaluate the Area under the plasma concentration versus time curve.
Time Frame
Up to 24 days
Title
Cmax of ASC41
Description
Evaluate the Peak Plasma Concentration.
Time Frame
Up to 24 days
Secondary Outcome Measure Information:
Title
t1/2 of ASC41
Description
Evaluate the Terminal-Phase Half-Life.
Time Frame
Up to 24 days
Title
CL/F of ASC41
Description
Evaluate the Apparent Systemic Clearance.
Time Frame
Up to 24 days
Title
Vd/F of ASC41
Description
Evaluate the Apparent Volume of Distribution.
Time Frame
Up to 24 days
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 24 days.
Time Frame
Up to 24 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
ICON early Phase Services LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.
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