NCT05602597

HMPL-689 Drug Interaction Study With CYP3A Inhibitor/CYP2C9 Inhibitor/CYP3A Inducer/PPI

A Phase 1, Open-Label, 4-Part, Fixed-Sequence Study to Assess the Effect of Itraconazole, a Strong CYP3A Inhibitor, the Effect of Fluconazole, a Moderate CYP3A/2C9 Inhibitor, the Effect of Rifampin, a Strong CYP3A Inducer, and the Effect of Rabeprazole, a Proton Pump Inhibitor on the Pharmacokinetics of HMPL-689 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

An open-label study to determine effect of Itraconazole, Fluconazole, Rifampin, and Rabeprazole on the PK of HMPL-689

Detailed description

A phase 1, open-label, 4-part, 2-period, fixed-sequence study to assess the effect of Itraconazole, a strong CYP3A inhibitor, the effect of Fluconazole, a moderate CYP3A/2C9 inhibitor, the effect of Rifampin, a strong CYP3A inducer, and the effect of Rabeprazole, a proton pump inhibitor on the pharmacokinetics (PK) of a single oral dose of HMPL-689 in study participants. The secondary objective is to evaluate the safety of a single oral dose of HMPL-689 administered with and without Itraconazole, Fluconazole, Rifampin, or Rabeprazole in study participants.

Conditions

• Relapsed or Refractory Lymphoma

Interventions

Type	Name	Description
DRUG	Itraconazole 200 mg	Study participants will be administered 200 mg itraconazole by mouth twice daily after the pharmacokinetic blood draw on Day 3 and once daily on Days 4 to 10, inclusive.
DRUG	Fluconazole 400 mg	Study participants will be administered 400 mg fluconazole by mouth daily on Day 3 after the pharmacokinetic blood draw, and 200 mg fluconazole by mouth daily on Days 4 to 10, inclusive.
DRUG	Rifampin 600 mg	Study participants will be administered 600 mg rifampin by mouth daily starting on Day 3, after the pharmacokinetic blood draw, and on Days 4 to 11, inclusive.
DRUG	Rabeprazole 40 mg	Study participants will be administered 40 mg rabeprazole by mouth daily on Day 3, after the pharmacokinetic blood draw, and on Days 4 to 9, inclusive.

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-08-06
• Completion: 2022-08-06
• First posted: 2022-11-02
• Last updated: 2024-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study