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

Study identifier:D5084C00015

ClinicalTrials.gov identifier:NCT05888207

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Healthy male subjects

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Fluvoxamine, Savolitinib

Sex

Male

Actual Enrollment

16

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 02 Jun 2023
Primary Completion Date: 17 Aug 2023
Study Completion Date: 17 Aug 2023

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria