drugset
drugset / Trial / NCT05582187

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

NCT05582187 ↗

Phase 1 Completed 28 enrolled Basilea Pharmaceutica Biomedical Advanced Research and Development Authority · collab
Non-randomizedParallel-groupOpen-labelBasic science

Summary

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.

Timeline

Start
2022-10-31
Primary completion
2025-10-16
Completion
2025-10-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Fosmanogepix Small molecule 1 unknown Oral
Subject Fosmanogepix Small molecule 2 unknown Oral

Indications

No indication recorded.