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

Phase 1

Completed

• Conditions: Hyperlipidemia; Healthy; NAFLD
• Interventions: Drug: ASC41 tablet

• Registration Number: NCT04692025
• Lead Sponsor: Gannex Pharma Co., Ltd.

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-∞.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12-27
• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-31
• Primary Completion: 2021-01-14
• Study Completion: 2021-01-21
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 19kg/m2 ≤ BMI <40kg/m2.

Key

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	ASC41 tablet	ASC41 one tablet, on Day 1 before meal；ASC41 one tablet, on Day 15 after meal.
Group 2	ASC41 tablet	ASC41 one tablet, on Day 1 after meal；ASC41 one tablet, on Day 15 before meal.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hunan provincial people's hospital; 🇨🇳 Changsha, Hunan, China