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

Ascletis

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ASC40; Drug: rifampicin; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT04843449

ASC40-102

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Inhibitor group

Experimental group

Description:

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.

Treatment:

Drug: ASC40

Drug: Itraconazole

Inducer group

Experimental group

Description:

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.

Treatment:

Drug: ASC40

Drug: rifampicin