Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects
- Registration Number
- NCT04843449
- Lead Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
-19kg/m2 ≤ BMI <40kg/m2.
Key
- History of, or current digestive system, nervous system disease, etc..
- Taking drugs or foods that inhibit or induce the liver's metabolism.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inducer group rifampicin 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. Inducer group ASC40 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. Inhibitor group ASC40 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. Inhibitor group Itraconazole 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.
- Primary Outcome Measures
Name Time Method AUC of ASC40 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.
Cmax of ASC40 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
Name Time Method t1/2 of ASC40 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.
CL/F of ASC40 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.
Vd/F of ASC40 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.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 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.
Trial Locations
- Locations (1)
Hunan provincial people's hospital
🇨🇳Changsha, Hunan, China