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DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.

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ClinicalTrials.gov Identifier: NCT04845646
Recruitment Status : Completed
First Posted : April 15, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Gannex Pharma Co., Ltd.

Brief Summary:
The primary objective of this study is to evaluate the effect of itraconazole, a strong inhibitor)of cytochrome P4503A , and phenytoin a strong inducer of cytochrome P450 3A, CYP3A4, CYP1A2 and CYP2C19 on the pharmacokinetics of ASC41, a THR beta agonist tables in healthy subjects. The PK, Safety and Tolerability of ASC 41 in Subjects with NAFLD will also be evaluated. Approximately 24 subjects including 16 healthy volunteers (HVs) and 8 subjects with NAFLD will be enrolled. This study consists of 3 cohorts.

Condition or disease Intervention/treatment Phase
Healthy NAFLD Drug: ASC41 Drug: Itraconazole Drug: Phenytoin Phase 1

Detailed Description:
This multiarm study in HVs and subjects with NAFLD is designed to further characterize the PK, safety and tolerability of ASC41. Part I of the study will assess the effect of itraconazole and phenytoin on the single-dose PK of ASC41 in HVs. Part II of the study will evaluate the PK, safety and tolerability of a single dose of ASC41 in subjects with NAFLD. The pharmacokinetics of ASC41 and its metabolite ASC41-A will be assessed in both parts I and II. The secondary objective of the study is to characterize the safety and tolerability of oral ASC41 in subjects in the U.S. with NAFLD and in HVs. Approximately 24 male and female participants will be enrolled. This study consists of 3 cohorts.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Open Label, Drug-Drug Interaction, Study to Evaluate the Effect of Itraconazole and Phenytoin on the Pharmacokinetics of ASC41 in Healthy Volunteers and A Study to Evaluate the PK, Safety and Tolerability in Subjects With Non-alcoholic Fatty Liver Disease (NAFLD).
Actual Study Start Date : March 16, 2021
Actual Primary Completion Date : June 10, 2021
Actual Study Completion Date : June 10, 2021


Arm Intervention/treatment
Experimental: ASC41 + Itraconazole group
  1. ASC41 5 mg po, One 5 mg ASC41 tablet on day 1 and 11.
  2. Itraconazole oral capsule 200 mg po qd (2 capsules given 1x/day or 200 mg/day) on days 6-16.
Drug: ASC41
5mg/tablet

Drug: Itraconazole
200mg/capsule

Experimental: ASC41 + Phenytoin group
  1. ASC41 5 mg po, One 5 mg ASC41 tablet on day 1 and 19.
  2. Phenytoin oral capsule 300 mg (100 mg 3 x/day) on days 6-19.
Drug: ASC41
5mg/tablet

Drug: Phenytoin
300mg/capsule

Experimental: ASC41 group
(1) ASC41 5 mg po. One 5 mg ASC41 tablet on day 1.
Drug: ASC41
5mg/tablet




Primary Outcome Measures :
  1. AUC of ASC41 [ Time Frame: Up to 24 days ]
    Evaluate the Area under the plasma concentration versus time curve.

  2. Cmax of ASC41 [ Time Frame: Up to 24 days ]
    Evaluate the Peak Plasma Concentration.


Secondary Outcome Measures :
  1. t1/2 of ASC41 [ Time Frame: Up to 24 days ]
    Evaluate the Terminal-Phase Half-Life.

  2. CL/F of ASC41 [ Time Frame: Up to 24 days ]
    Evaluate the Apparent Systemic Clearance.

  3. Vd/F of ASC41 [ Time Frame: Up to 24 days ]
    Evaluate the Apparent Volume of Distribution.

  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 24 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 24 days.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Part I Healthy subjects between 18 to 55 years of age
  • Part II

    1. Subjects with NAFLD
    2. Subjects between 18 to 65 years of age

Key Exclusion criteria:

  • Part I

    1. A history of thyroid disease
    2. A history of, or current liver disease, or liver injuries
    3. Platelet count <150,000/mcL
    4. INR> 1.2
    5. History of, or current electrocardiogram (ECG) abnormalities, arrhythmias or heart valve diseases judged to be clinically significant by the investigator
  • Part II

    1. A history of thyroid disease
    2. Current or history of cirrhosis or decompensated liver disease
    3. AST or ALT > 5X ULN
    4. DBIL > ULN
    5. Acute or chronic liver disease other than NAFLD
    6. A history of bariatric surgery
    7. HbA1c >9.5% at screening
    8. Testosterone or estrogen replacement therapy
    9. Inducers or inhibitors of CYP3A4, including herbal therapies such as St John's Wort (CYP3A4 Inducer)

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): NCT04845646


Locations
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United States, Texas
ICON early Phase Services LLC
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Gannex Pharma Co., Ltd.
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Responsible Party: Gannex Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT04845646    
Other Study ID Numbers: ASC41-105
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gannex Pharma Co., Ltd.:
Healthy
NAFLD
DDI (Drug-Drug Interaction)
Itraconazole
Phenytoin
THR beta agonist
ASC41
Additional relevant MeSH terms:
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Non-alcoholic Fatty Liver Disease
Fatty Liver
Liver Diseases
Digestive System Diseases
Itraconazole
Phenytoin
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers