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

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-∞.

Study Overview

• Status: Completed
• Conditions: Healthy; NAFLD; Hyperlipidemia
• Intervention / Treatment: Drug: ASC41 tablet

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Hunan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• 19kg/m2 ≤ BMI <40kg/m2.

Key Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; ASC41 one tablet, on Day 1 before meal；ASC41 one tablet, on Day 15 after meal.	Drug: ASC41 tablet; Oral tablet
Experimental: Group 2; ASC41 one tablet, on Day 1 after meal；ASC41 one tablet, on Day 15 before meal.	Drug: ASC41 tablet; Oral tablet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gannex Pharma Co., Ltd.
• Collaborators: Hunan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2020
• Primary Completion (Actual): January 14, 2021
• Study Completion (Actual): January 21, 2021

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Healthy Volunteers; NAFLD; NASH; Hyperlipidemia; LDL-C
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: ASC41-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No