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

Completed · Phase 1

Conditions studied: Healthy, NAFLD

In brief

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.

Key facts

Study ID

NCT04845646

Run by

Gannex Pharma Co., Ltd.

People needed

24

Starts

2021-03-16

Expected to finish

2021-06-10

Last updated by the study team

2024-09-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

Where it is running

• ICON early Phase Services LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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