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A Clinical Trial of the Study Medicine (Called Fosmanogepix) in People With Hepatic Dysfunction.

Hepatic Impairment Clinical Trial

Official title:
A Phase 1, Open-label, Single-dose, Parallel Cohort Study to Assess the Pharmacokinetics and Safety of Fosmanogepix (PF 07842805) in Adult Participants With Varying Degrees of Hepatic Impairment

Clinical Trial Summary

The purpose of this study is to understand how fosmanogepix is processed in people with varying degrees of liver dysfunction. This study is seeking participants who have: - stable loss of liver function with mild, moderate, or advanced severity - none of underlying conditions possibly affecting the study medicine being absorbed by the body - liver dysfunction not due to acute worsening of liver All participants will receive 1 dose of fosmanogepix by mouth before breakfast on the first day at the study clinic. Serial blood samples will be collected to understand how fosmanogepix is changed and eliminated from the body. Participants will also receive physical examination and other tests. This will help to understand if fosmanogepix is safe. Participants will be involved in this study for 4 to 9 weeks (maximum). There will be 2 to 4 study visits at the study clinic.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05582187
Study type Interventional
Source Basilea Pharmaceutica
Contact
Status Active, not recruiting
Phase Phase 1
Start date October 31, 2022
Completion date December 31, 2024
View Details
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