NCT06255951

Studies Evaluating the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of TY-9591 Tablets in Healthy Subjects

This is a Single-center, Two-sequence, Open-label, Two-cycle Drug-drug Interaction (DDI) Study in Healthy Subjects. To Evaluate the Effects of Itraconazole Capsules, a Strong Inhibitor of CYP3A4, and Rifampicin Capsules, a Strong Inducer, on the Pharmacokinetics of TY-9591 Tablets After a Single Oral Dose

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: TYK Medicines, Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Studies evaluating the effects of itraconazole or rifampicin on the pharmacokinetics of TY-9591 tablets in healthy subjects

Detailed description

To evaluate the pharmacokinetics of TY-9591 tablets in healthy Chinese subjects after a single oral administration. To evaluate the effects of itraconazole/rifampicin on the pharmacokinetics of TY-9591 and its metabolites D1 and D2 after oral administration of TY-9591 tablets.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Itraconazole	The study was divided into two sequences with a planned enrollment of 48 healthy adult subjects (24 in each sequence). PartA was the itraconazole study sequence, which was used to study the effect of itraconazole on the pharmacokinetic characteristics of TY-9591 tablets after multiple doses.
DRUG	Rifampicin	The study was divided into two sequences with a planned enrollment of 48 healthy adult subjects (24 in each sequence). PartB was the rifampin study sequence, which investigated the effect of multiple doses of rifampin on the pharmacokinetic profile of TY-9591 tablets.

Timeline

• Start date: 2024-03-12
• Primary completion: 2024-05-23
• Completion: 2024-12-27
• First posted: 2024-02-13
• Last updated: 2024-12-30

Locations

1 site across 1 country: China