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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04692025
• Other study ID #: ASC41-103
• Status: Completed
• Phase: Phase 1
• Start date: December 27, 2020
• Est. completion date: January 21, 2021

Study information

• Verified date: December 2020
• Source: Gannex Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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-∞.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 21, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Key Inclusion Criteria:

• 19kg/m2 = BMI <40kg/m2.

Key Exclusion Criteria:

• A history of thyroid disease.

• History of, or current liver disease.

Related Conditions & MeSH terms

• Healthy
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• NAFLD

Intervention

Drug:
• ASC41 tablet
Oral tablet

Locations

Country	Name	City	State
China	Hunan provincial people's hospital	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Gannex Pharma Co., Ltd.	Hunan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Cmax of ASC41	Evaluate the Peak Plasma Concentration after single oral dose of ASC41 administered to healthy volunteers.	Up to 19 days
Secondary	t1/2 of ASC41	Evaluate the Terminal-Phase Half-Life after single oral dose of ASC41 administered to healthy volunteers.	Up to 19 days
Secondary	CL/F of ASC41	Evaluate the Apparent Systemic Clearance after single oral dose of ASC41 administered to healthy volunteers.	Up to 19 days
Secondary	Vd/F of ASC41	Evaluate the Apparent Volume of Distribution after single oral dose of ASC41 administered to healthy volunteers.	Up to 19 days
Secondary	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