Trials / Completed
CompletedNCT05685719
A Study to Evaluate the Relative Bioavailability of STI-1558 and the Effect of Itraconazole and Rifampin on the Pharmacokinetics of STI-1558
A Study to Evaluate the Relative Bioavailability of Different Strengths of STI-1558 Capsules and the Effect of Strong CYP3A4 Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics of STI-1558 in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Zhejiang ACEA Pharmaceutical Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-01-04
- Primary completion
- 2023-03-15
- Completion
- 2023-11-03
- First posted
- 2023-01-17
- Last updated
- 2023-12-07
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05685719. Inclusion in this directory is not an endorsement.