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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhibitor group | Experimental |
|
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| Inducer group | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC40 | Drug | Oral tablets |
| |
| 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 |
| 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 |
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Key Inclusion Criteria:
-19kg/m2 ≤ BMI <40kg/m2.
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan provincial people's hospital | Changsha | Hunan | China |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole |
| Drug |
Oral capsules |
|
| rifampicin | Drug | Oral capsules |
|
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 |
| D010879 |
| Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |