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NCT05582187 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.
A Phase 1 study of Hepatic Impairment, sponsored by Basilea Pharmaceutica.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 2
- Study locations
NCT05582187: Completed Phase 1 study of Hepatic Impairment, sponsored by Basilea Pharmaceutica.
NCT05582187 is a Phase 1 study of Hepatic Impairment that has completed, run by Basilea Pharmaceutica. The registered enrollment target is 28 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (22% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05582187, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Basilea Pharmaceutica.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Fosmanogepix
Study Locations (2)
California
- Inland Empire Liver Foundation - Rialto
Florida
- Genesis Clinical Research, LLC - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-10-31 |
| Est. Completion | 2025-10-16 |
| Phase | Phase 1 |
What the finished NCT05582187 record still lists
NCT05582187 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Fosmanogepix is the first listed.
NCT05582187 reports a single indexed study location in California, Florida.
Frequently Asked Questions
What is clinical trial NCT05582187 about?
NCT05582187 is a clinical study titled "A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.". 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...
What is the current status of trial NCT05582187?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2022-10-31. Estimated completion is 2025-10-16.
What conditions does trial NCT05582187 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT05582187?
The interventions under investigation include: Fosmanogepix (DRUG).
Who is sponsoring clinical trial NCT05582187?
This trial is sponsored by Basilea Pharmaceutica, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05582187 being conducted?
This trial has 2 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05582187's enrollment target sits among peer trials
28 27th of 48 higher than 20 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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