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Phase I Study: Itraconazole Effect on Pharmacokinetics of HS-10506

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Summary

The NIH ClinicalTrials.gov registry has registered Phase I clinical trial NCT07535970, a single-center, open-label, fixed-sequence, self-controlled study evaluating the effect of itraconazole (a CYP3A inhibitor) on the pharmacokinetics of HS-10506 tablets in healthy Chinese adult participants. The trial is categorized as Phase 1 and is expected to begin on April 17, 2026.

Published by NIH on changeflow.com . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

ClinicalTrials.gov has added registration for Phase I trial NCT07535970, a single-center study evaluating the effect of itraconazole (CYP3A inhibitor) on the pharmacokinetics of HS-10506 tablets in healthy Chinese adult participants. The study uses a fixed-sequence, self-controlled design with two interventions: HS-10506 and itraconazole.

For pharmaceutical sponsors and clinical investigators, this trial registration signals ongoing drug interaction research involving CYP3A enzyme inhibition and represents a standard Phase I clinical study entry in the NIH registry. The registration provides transparency regarding upcoming clinical research but does not create compliance obligations for regulated entities.

Archived snapshot

Apr 18, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Participants

Phase 1 NCT07535970 Kind: PHASE1 Apr 17, 2026

Abstract

A single-center, open-label, fixed-sequence, self-controlled phase I clinical trial aimed at evaluating the effect of itraconazole capsules(CYP3A inhibitor) on the pharmacokinetics of HS-10506 tablets in healthy participants.

Conditions: Healthy Participants

Interventions: HS-10506, Itraconazole

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Last updated

Classification

Agency
NIH
Published
September 17th, 2024
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07535970

Who this affects

Applies to
Pharmaceutical companies Clinical investigators
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug interaction study Pharmacokinetics assessment
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Clinical Investigations

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