NCT05888207

A Study to Assess the Effects of Fluvoxamine on Savolitinib Exposure in Healthy Male Subjects

A Phase I, Open-label, Fixed-sequence Study to Assess the Effects of Strong CYP1A2 Inhibitor (Fluvoxamine) on Savolitinib Exposure in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will assess the effects of strong CYP1A2 (Cytochrome P450 1A2) inhibitor (fluvoxamine) on savolitinib exposure in healthy male subjects, performed at a single clinical unit.

Detailed description

This study will be a Phase I, open-label, fixed-sequence, 2-treatment period study. The study will consist of 2 periods. During period 1 of the study, each subject will receive a single oral dose of savolitinib following an overnight fast. A low-fat breakfast will be provided prior to dosing. There will be a minimum washout period of 10 days (14 days between two successive savolitinib doses) between period 1 and period 2. During period 2 of the study, subject will take oral doses of fluvoxamine alone from Days 1 to 4. There would be no dietary restrictions for fluvoxamine dosing. On Day 5, subjects will take a single oral dose of savolitinib and oral dose of fluvoxamine. On Day 6, subject will receive an oral dose of fluvoxamine alone. Each subject would be involved in the study for 9 weeks (including screening window).

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
DRUG	Savolitinib	Savolitinib will be administered as a single oral dose on Day 1 of Period 1 and on Day 5 of Period 2.
DRUG	Fluvoxamine	Only fluvoxamine will be administered as a twice daily oral dose from Days 1 to 4 of Period 2. On Day 5 of Period 2, subject will receive a twice daily oral dose of fluvoxamine along with savolitinib. On Day 6 of Period 2, subject will receive a twice daily oral dose of fluvoxamine alone.

Timeline

• Start date: 2023-06-02
• Primary completion: 2023-08-17
• Completion: 2023-08-17
• First posted: 2023-06-05
• Last updated: 2023-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study