Studies Evaluating the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of TY-9591 Tablets in Healthy Subjects - Trial NCT06255951

Name: Clinical Trial NCT06255951
Creator: TYK Medicines, Inc
Keywords: NSCLC, Itraconazole, Phase 1, drug, clinical trial, China

Access comprehensive clinical trial information for NCT06255951 through Pure Global AI's free database. This Phase 1 trial is sponsored by TYK Medicines, Inc and is currently Recruiting. The study focuses on NSCLC. Target enrollment is 48 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

Free Database

840K+ Trials

NCT06255951

Phase 1

Recruiting

drug

Trial Details

ClinicalTrials.gov • NCT06255951

View on ClinicalTrials.gov

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

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

Study Focus

Disease/Condition

NSCLC

Drug/Device/Intervention

Itraconazole

Study Type

Interventional

Intervention Type

drug

Sponsor & Location

Primary Sponsor

TYK Medicines, Inc

Location

Guangdong, China

Timeline & Enrollment

Phase

Phase 1

Start Date

Mar 04, 2024

End Date

Aug 05, 2024

Enrollment

48 participants

Primary Outcome

Peak plasma concentrations (Cmax) of TY-9591 and its metabolites D1 and D2,Area under the concentration-time curve from 0 to the last quantifiable time point after dose administration (AUC0-t),Area under the concentration-time curve from 0 to infinity (AUC0-inf), as data permit

Summary

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

Data Source

Registry

ClinicalTrials.gov

Trial ID

NCT06255951

Type

Non-Device Trial