Back to resultsStudy to Evaluate the Effect of Food on the Pharmacokinetics of ASC41 in Healthy Volunteers
Primary Purpose
Healthy, NAFLD, Hyperlipidemia
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ASC41 tablet
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Healthy Volunteers, NAFLD, NASH, Hyperlipidemia, LDL-C
Eligibility Criteria
Key Inclusion Criteria:
- 19kg/m2 ≤ BMI <40kg/m2.
Key Exclusion Criteria:
- A history of thyroid disease.
- History of, or current liver disease.
Sites / Locations
- Hunan provincial people's hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
ASC41 one tablet, on Day 1 before meal；ASC41 one tablet, on Day 15 after meal.
ASC41 one tablet, on Day 1 after meal；ASC41 one tablet, on Day 15 before meal.
Outcomes
Primary Outcome Measures
AUC of ASC41
Evaluate the Area under the plasma concentration versus time curve after single oral dose of ASC41 administered to healthy volunteers.
Cmax of ASC41
Evaluate the Peak Plasma Concentration after single oral dose of ASC41 administered to healthy volunteers.
Secondary Outcome Measures
t1/2 of ASC41
Evaluate the Terminal-Phase Half-Life after single oral dose of ASC41 administered to healthy volunteers.
CL/F of ASC41
Evaluate the Apparent Systemic Clearance after single oral dose of ASC41 administered to healthy volunteers.
Vd/F of ASC41
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]
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
Full Information
NCT ID
NCT04692025
First Posted
December 29, 2020
Last Updated
April 6, 2021
Sponsor
Gannex Pharma Co., Ltd.
Collaborators
Hunan Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04692025
Brief Title
Study to Evaluate the Effect of Food on the Pharmacokinetics of ASC41 in Healthy Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 27, 2020 (Actual)
Primary Completion Date
January 14, 2021 (Actual)
Study Completion Date
January 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gannex Pharma Co., Ltd.
Collaborators
Hunan Provincial People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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-∞.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, NAFLD, Hyperlipidemia
Keywords
Healthy Volunteers, NAFLD, NASH, Hyperlipidemia, LDL-C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
ASC41 one tablet, on Day 1 before meal；ASC41 one tablet, on Day 15 after meal.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
ASC41 one tablet, on Day 1 after meal；ASC41 one tablet, on Day 15 before meal.
Intervention Type
Drug
Intervention Name(s)
ASC41 tablet
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
AUC of ASC41
Description
Evaluate the Area under the plasma concentration versus time curve after single oral dose of ASC41 administered to healthy volunteers.
Time Frame
Up to 19 days
Title
Cmax of ASC41
Description
Evaluate the Peak Plasma Concentration after single oral dose of ASC41 administered to healthy volunteers.
Time Frame
Up to 19 days
Secondary Outcome Measure Information:
Title
t1/2 of ASC41
Description
Evaluate the Terminal-Phase Half-Life after single oral dose of ASC41 administered to healthy volunteers.
Time Frame
Up to 19 days
Title
CL/F of ASC41
Description
Evaluate the Apparent Systemic Clearance after single oral dose of ASC41 administered to healthy volunteers.
Time Frame
Up to 19 days
Title
Vd/F of ASC41
Description
Evaluate the Apparent Volume of Distribution after single oral dose of ASC41 administered to healthy volunteers.
Time Frame
Up to 19 days
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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
Time Frame
Up to 19 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
19kg/m2 ≤ BMI <40kg/m2.
Key Exclusion Criteria:
A history of thyroid disease.
History of, or current liver disease.
Facility Information:
Facility Name
Hunan provincial people's hospital
City
Changsha
State/Province
Hunan
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study to Evaluate the Effect of Food on the Pharmacokinetics of ASC41 in Healthy Volunteers
We'll reach out to this number within 24 hrs