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HMPL-523 CYP3A/P-gp Inhibitor and CYP Inducer Study

NCT05720767 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-03-01

No results posted yet for this study

Summary

A Phase 1, Open-label, 2-Part, 2-Period Fixed-Sequence Crossover Study to Assess the Effect of Itraconazole, a CYP3A and P-glycoprotein Inhibitor, and the Effect of Rifampin, a CYP Enzyme Inducer, on the Pharmacokinetics of HMPL-523 in Healthy Volunteers

Conditions

  • Relapsed or Refractory Lymphoma

Interventions

DRUG

HMPL-523

HMPL-523 is a selective small-molecule SYK inhibitor.

DRUG

Itraconazole

Itraconazole is an FDA approved synthetic triazole antifungal agent

DRUG

Rifampin

Rifampin is an FDA approved semisynthetic antiobiotic derivative indicated in the treatment of both tuberculosis and meningococcal carrier state

Sponsors & Collaborators

  • Hutchmed

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-11-04
Primary Completion
2023-02-05
Completion
2023-02-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05720767 on ClinicalTrials.gov