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Completed

NCT Number: NCT04692025

Study to Evaluate the Effect of Food on the Pharmacokinetics of ASC41 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-∞.

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Key information

Conditions

Healthy Digestive System Diseases Dyslipidemias Fatty Liver Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Liver Diseases Metabolic Diseases NAFLD Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hunan provincial people's hospital

Changsha, Hunan, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 19kg/m2 ≤ BMI <40kg/m2.

Key Exclusion Criteria:

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

Treatment and study plan

ASC41 tablet

Drug

Oral tablet

Primary outcomes

  1. AUC of ASC41

    Time frame: Up to 19 days

    Evaluate the Area under the plasma concentration versus time curve after single oral dose of ASC41 administered to healthy volunteers.

  2. Cmax of ASC41

    Time frame: Up to 19 days

    Evaluate the Peak Plasma Concentration after single oral dose of ASC41 administered to healthy volunteers.

Secondary outcomes

  1. t1/2 of ASC41

    Time frame: Up to 19 days

    Evaluate the Terminal-Phase Half-Life after single oral dose of ASC41 administered to healthy volunteers.

  2. CL/F of ASC41

    Time frame: Up to 19 days

    Evaluate the Apparent Systemic Clearance after single oral dose of ASC41 administered to healthy volunteers.

  3. Vd/F of ASC41

    Time frame: Up to 19 days

    Evaluate the Apparent Volume of Distribution after single oral dose of ASC41 administered to healthy volunteers.

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Gannex Pharma Co., Ltd.

Industry

Collaborators

  • Hunan Provincial People's Hospital

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 31, 2020
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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