drugset / Trial / NCT04845646
DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-03-16
- Primary completion
- 2021-06-10
- Completion
- 2021-06-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ASC41 | Unknown | 5 mg | Oral |
| Subject | Itraconazole | Small molecule | 200 mg | Oral |
| Subject | Phenytoin | Unknown | 300 mg | Oral |