Study to Evaluate the Effect of Food on the Pharmacokinetics of ASC41 in Healthy Volunteers

A Randomized, Single Center, Open-label, Phase I Study to Evaluate the Effect of Food and Fasting on the Pharmacokinetics of ASC41 Tablets in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04692025

Enrollment

Registered

2020-12-31

Start date

2020-12-27

Completion date

2021-01-21

Last updated

2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Hyperlipidemia, NAFLD

Keywords

Healthy Volunteers, NAFLD, NASH, Hyperlipidemia, LDL-C

Brief summary

This study is to evaluate the effect of food on the pharmacokinetics of a single dose of ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic parameters of Tmax, Cmax, AUC0-t, AUC0-∞.

Interventions

DRUGASC41 tablet

Oral tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * 19kg/m2 ≤ BMI \<40kg/m2. Key

Exclusion criteria

* A history of thyroid disease. * History of, or current liver disease.

Design outcomes

Primary

Measure	Time frame	Description
AUC of ASC41	Up to 19 days	Evaluate the Area under the plasma concentration versus time curve after single oral dose of ASC41 administered to healthy volunteers.
Cmax of ASC41	Up to 19 days	Evaluate the Peak Plasma Concentration after single oral dose of ASC41 administered to healthy volunteers.

Secondary

Measure	Time frame	Description
t1/2 of ASC41	Up to 19 days	Evaluate the Terminal-Phase Half-Life after single oral dose of ASC41 administered to healthy volunteers.
CL/F of ASC41	Up to 19 days	Evaluate the Apparent Systemic Clearance after single oral dose of ASC41 administered to healthy volunteers.
Vd/F of ASC41	Up to 19 days	Evaluate the Apparent Volume of Distribution after single oral dose of ASC41 administered to healthy volunteers.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Up to 19 days	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 19 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026