Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects
Study Details
Study Description
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 |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Inhibitor group 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
Oral tablets
Drug: Itraconazole
Oral capsules
|
| Experimental: Inducer group 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
Oral tablets
Drug: rifampicin
Oral capsules
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hunan provincial people's hospital | Changsha | Hunan | China |
Sponsors and Collaborators
- Ascletis Pharmaceuticals Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ASC40-102