DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.

NCT ID: NCT04845646

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2021-06-10

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.

Conditions

Healthy; NAFLD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASC41 + Itraconazole group

1. ASC41 5 mg po, One 5 mg ASC41 tablet on day 1 and 11.

2. Itraconazole oral capsule 200 mg po qd (2 capsules given 1x/day or 200 mg/day) on days 6-16.

Group Type: EXPERIMENTAL

ASC41

Intervention Type: DRUG

5mg/tablet

Itraconazole

Intervention Type: DRUG

200mg/capsule

ASC41 + Phenytoin group

1. ASC41 5 mg po, One 5 mg ASC41 tablet on day 1 and 19.

2. Phenytoin oral capsule 300 mg (100 mg 3 x/day) on days 6-19.

Group Type: EXPERIMENTAL

ASC41

Intervention Type: DRUG

5mg/tablet

Phenytoin

Intervention Type: DRUG

300mg/capsule

ASC41 group

(1) ASC41 5 mg po. One 5 mg ASC41 tablet on day 1.

Group Type: EXPERIMENTAL

ASC41

Intervention Type: DRUG

5mg/tablet

Interventions

ASC41

5mg/tablet

Intervention Type: DRUG

Itraconazole

200mg/capsule

Intervention Type: DRUG

Phenytoin

300mg/capsule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Part I Healthy subjects between 18 to 55 years of age
• Part II

1. Subjects with NAFLD

2. Subjects between 18 to 65 years of age

Exclusion Criteria

• Part I

1. A history of thyroid disease

2. A history of, or current liver disease, or liver injuries

3. Platelet count <150,000/mcL

4. INR> 1.2

5. History of, or current electrocardiogram (ECG) abnormalities, arrhythmias or heart valve diseases judged to be clinically significant by the investigator

• Part II

1. A history of thyroid disease

2. Current or history of cirrhosis or decompensated liver disease

3. AST or ALT > 5X ULN

4. DBIL > ULN

5. Acute or chronic liver disease other than NAFLD

6. A history of bariatric surgery

7. HbA1c >9.5% at screening

8. Testosterone or estrogen replacement therapy

9. Inducers or inhibitors of CYP3A4, including herbal therapies such as St John's Wort (CYP3A4 Inducer)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gannex Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICON early Phase Services LLC

San Antonio, Texas, United States

Countries

United States

Other Identifiers

ASC41-105

Identifier Type: -

Identifier Source: org_study_id