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Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04843449
Recruitment Status : Completed
First Posted : April 13, 2021
Last Update Posted : August 23, 2021
Sponsor:
Information provided by (Responsible Party):
Ascletis Pharmaceuticals Co., Ltd.

Study Description
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Brief Summary:
The primary objective of this study is to evaluate the effects of itraconazole (a strong inhibitor of cytochrome P450 3A (CYP3A)) and rifampicin (a strong inducer of CYP3A) on the pharmacokinetics of ASC40 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: ASC40 Drug: Itraconazole Drug: rifampicin Phase 1

Study Design
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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: A Phase I, Open Label, Drug-drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects
Actual Study Start Date : April 4, 2021
Actual Primary Completion Date : May 6, 2021
Actual Study Completion Date : May 14, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Inhibitor group
  1. ASC40 50mg, once daily on the 1st and 11th days before meal;
  2. Itraconazole 200mg, once daily from the 6th day to the 15th day.
 Drug: ASC40
Oral tablets

Drug: Itraconazole
Oral capsules
Experimental: Inducer group
  1. ASC40 50mg, once daily on the 1st and 19th days before meal;
  2. Rifampicin 600mg, once daily from the 6th day to the 19th day.
 Drug: ASC40
Oral tablets

Drug: rifampicin
Oral capsules


Outcome Measures
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Primary Outcome Measures :
  1. AUC of ASC40 [ Time Frame: Up to 24 days ]
    Evaluate the Area under the Plasma Concentration Versus Time Curve after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.

  2. Cmax of ASC40 [ Time Frame: Up to 24 days ]
    Evaluate the Peak Plasma Concentration after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.


Secondary Outcome Measures :
  1. t1/2 of ASC40 [ Time Frame: Up to 24 days ]
    Evaluate the Terminal-Phase Half-Life after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.

  2. CL/F of ASC40 [ Time Frame: Up to 24 days ]
    Evaluate the Apparent Systemic Clearance after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.

  3. Vd/F of ASC40 [ Time Frame: Up to 24 days ]
    Evaluate the Apparent Volume of Distribution after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.

  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

-19kg/m2 ≤ BMI <40kg/m2.

Key Exclusion Criteria:

  • History of, or current digestive system, nervous system disease, etc..
  • Taking drugs or foods that inhibit or induce the liver's metabolism.
Contacts and Locations
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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): NCT04843449


Locations
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China, Hunan
Hunan provincial people's hospital
Changsha, Hunan, China
Sponsors and Collaborators
Ascletis Pharmaceuticals Co., Ltd.
More Information
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Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT04843449    
Other Study ID Numbers: ASC40-102
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
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 Ascletis Pharmaceuticals Co., Ltd.:
Healthy Volunteers
DDI (Drug-Drug Interaction)
Itraconazole
Rifampicin
ASC40
Additional relevant MeSH terms:
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Itraconazole
Rifampin
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
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers