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

NCT ID: NCT04843449

Last Updated: 2021-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-04

Study Completion Date

2021-05-14

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inhibitor group

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.

Group Type EXPERIMENTAL

ASC40

Intervention Type DRUG

Oral tablets

Itraconazole

Intervention Type DRUG

Oral capsules

Inducer group

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.

Group Type EXPERIMENTAL

ASC40

Intervention Type DRUG

Oral tablets

rifampicin

Intervention Type DRUG

Oral capsules

Interventions

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ASC40

Oral tablets

Intervention Type DRUG

Itraconazole

Oral capsules

Intervention Type DRUG

rifampicin

Oral capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-19kg/m2 ≤ BMI \<40kg/m2.

Exclusion Criteria

* History of, or current digestive system, nervous system disease, etc..
* Taking drugs or foods that inhibit or induce the liver's metabolism.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ascletis Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hunan provincial people's hospital

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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ASC40-102

Identifier Type: -

Identifier Source: org_study_id

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