NCT05571787

HMPL-523 Food Effect and Proton Pump Inhibitor Study

A Phase 1, Open-label, 4-period, Randomized 6-sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of HMPL-523 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Open-label, 4-Period, Randomized 6-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of HMPL-523 in Healthy Volunteers

Detailed description

This study will be a single-center, open-label, 4-period, randomized,6-sequence study conducted with 24 healthy male or female subjects. The study will consist of a Screening Phase (Screening and Day -1), a Treatment Phase (Periods1, 2, 3,and 4), and an End of Study (EOS) Phase. Screening must occur within 28 days before the first study drug administration. There will be a washout of at least 7days between 4 administrations of HMPL-523.Subjects in Periods 1, 2, and 3 will be randomized into 1 of 6 treatment sequences, with all subjects then receiving the same treatment in Period 4.

Conditions

• Relapsed or Refractory Lymphoma

Interventions

Type	Name	Description
DRUG	HMPL-523	700 mg HMPL-523 will be administered by mouth once daily on Day 1, Day 8, Day 15, and Day 26
DRUG	Rabeprazole	40 mg of rabeprazole will be administered by mouth once daily in the morning from Day 20 to Day 26

Timeline

• Start date: 2022-07-13
• Primary completion: 2022-09-22
• Completion: 2022-09-22
• First posted: 2022-10-07
• Last updated: 2023-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study