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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04843449
• Other study ID #: ASC40-102
• Status: Completed
• Phase: Phase 1
• Start date: April 4, 2021
• Est. completion date: May 14, 2021

Study information

• Verified date: August 2021
• Source: Ascletis Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 14, 2021
• Est. primary completion date: May 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ASC40
Oral tablets
• Itraconazole
Oral capsules
• rifampicin
Oral capsules

Locations

Country	Name	City	State
China	Hunan provincial people's hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Ascletis Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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