NCT05720767

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

A Phase 1, Open-label, 2-Part, 2-Period Fixed-Sequence Crossover Study to Assess the Effect of Itraconazole, and the Effect of Rifampin on the Pharmacokinetics of HMPL-523 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

This study will be a single-center, open-label, 2-part, 2-period fixed-sequence crossover study to be conducted with 28 healthy male and female volunteers. The study will consist of a Screening Phase (Screening and Day -1), a Treatment Phase (Period 1 and Period 2), and an End of Study (EOS) Phase.

Conditions

• Relapsed or Refractory Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-11-04
• Primary completion: 2023-02-05
• Completion: 2023-02-05
• First posted: 2023-02-09
• Last updated: 2023-03-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study