A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

The primary purpose of this open-label study is to characterize the plasma pharmacokinetics (PK) of manogepix (active moiety of fosmanogepix) in participants with varying degrees of hepatic function following administration of a single oral dose of fosmanogepix. 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.

Key facts

Study ID
NCT05582187
Run by
Basilea Pharmaceutica
People needed
28
Starts
2022-10-31
Expected to finish
2025-10-16
Last updated by the study team
2025-12-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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