Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05582187
The ClinicalTrials.gov registry entry for NCT05582187 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (22% lower). The listed sponsor is Basilea Pharmaceutica, which has 21 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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
Similar trials for Hepatic Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
RECRUITING · Phase 1
-
An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage
RECRUITING · Phase 1
-
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function
RECRUITING · Phase 1
-
A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems
RECRUITING · Phase 1
-
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
RECRUITING · Phase 1
-
A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.