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

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ClinicalTrials.gov Identifier: NCT04692025
Recruitment Status : Completed
First Posted : December 31, 2020
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Hunan Provincial People's Hospital
Information provided by (Responsible Party):
Gannex Pharma Co., Ltd.

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-∞.

Condition or disease Intervention/treatment Phase
Healthy NAFLD Hyperlipidemia Drug: ASC41 tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 27, 2020
Actual Primary Completion Date : January 14, 2021
Actual Study Completion Date : January 21, 2021

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • 19kg/m2 ≤ BMI <40kg/m2.

Key Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692025


Locations
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China, Hunan
Hunan provincial people's hospital
Changsha, Hunan, China
Sponsors and Collaborators
Gannex Pharma Co., Ltd.
Hunan Provincial People's Hospital
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Responsible Party: Gannex Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT04692025    
Other Study ID Numbers: ASC41-103
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gannex Pharma Co., Ltd.:
Healthy Volunteers
NAFLD
NASH
Hyperlipidemia
LDL-C
Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases