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

NCT05888207 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-08-29

No results posted yet for this study

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.

Conditions

  • Healthy Male Subjects

Interventions

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.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-06-02
Primary Completion
2023-08-17
Completion
2023-08-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT05888207 on ClinicalTrials.gov