NCT04692025

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-∞.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Dec 2020

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 27, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2021

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

18 days

First QC Date

December 29, 2020

Last Update Submit

September 25, 2024

Conditions

HealthyNAFLDHyperlipidemia

Keywords

Healthy VolunteersNAFLDNASHHyperlipidemiaLDL-C

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • t1/2 of ASC41

    Up to 19 days

  • CL/F of ASC41

    Up to 19 days

  • Vd/F of ASC41

    Up to 19 days

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Up to 19 days

Study Arms (2)

Group 1

EXPERIMENTAL

ASC41 one tablet, on Day 1 before meal；ASC41 one tablet, on Day 15 after meal.

Drug: ASC41 tablet

Group 2

EXPERIMENTAL

ASC41 one tablet, on Day 1 after meal；ASC41 one tablet, on Day 15 before meal.

Drug: ASC41 tablet

Interventions

ASC41 tabletDRUG

Oral tablet

Group 1Group 2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • kg/m2 ≤ BMI \<40kg/m2.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan provincial people's hospital

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseHyperlipidemias

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2020

First Posted

December 31, 2020

Study Start

December 27, 2020

Primary Completion

January 14, 2021

Study Completion

January 21, 2021

Last Updated

September 27, 2024

Record last verified: 2024-09

Locations

CN(1)