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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: ASC40
* Drug: Itraconazole
* Drug: rifampicin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhibitor group<br>ASC40 50mg, once daily on the 1st and 11th days before meal; Itraconazole 200mg, once daily from the 6th day to the 15th day. | Drug: ASC40<br>* Oral tablets<br>Drug: Itraconazole<br>* Oral capsules<br>|
| Experimental: Inducer group<br>ASC40 50mg, once daily on the 1st and 19th days before meal; Rifampicin 600mg, once daily from the 6th day to the 19th day. | Drug: ASC40<br>* Oral tablets<br>Drug: rifampicin<br>* Oral capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of ASC40 | 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. | Up to 24 days | 
| Cmax of ASC40 | 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. | Up to 24 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| t1/2 of ASC40 | 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. | Up to 24 days | 
| CL/F of ASC40 | 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. | Up to 24 days | 
| Vd/F of ASC40 | 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. | Up to 24 days | 
| 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 24 days. | Up to 24 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rifampicin, Healthy Volunteers, DDI (Drug-Drug Interaction), Itraconazole, ASC40