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A Study to Evaluate the Relative Bioavailability of STI-1558 and the Effect of Itraconazole and Rifampin on the Pharmacokinetics of STI-1558

NCT05685719 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2023-12-07

No results posted yet for this study

Summary

This is an open-label study. This study includes 2 parts, in which part 1 is a relative BA study, Part 2 is a DDI study. Part 1 and Part 2 could be performed in parallel.

Conditions

Interventions

DRUG

STI-1558

An oral small molecule prodrug that effectively inhibits the SARS-CoV-2 main protease (Mpro).

DRUG

Itraconazole

A strong CYP3A4 inhibitor

DRUG

Rifampin

A strong CYP3A4 inducer

Sponsors & Collaborators

  • Zhejiang ACEA Pharmaceutical Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-04
Primary Completion
2023-03-15
Completion
2023-11-03

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05685719 on ClinicalTrials.gov