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Antifungal Agent

Fosmanogepix for Liver Disease

Phase 1
Recruiting
Research Sponsored by Basilea Pharmaceutica
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will explore how fosmanogepix is processed in people with different levels of liver function. Participants will receive 1 dose of the medicine and have tests to assess safety.

Who is the study for?
This trial is for people with stable liver dysfunction of mild to severe levels who have a BMI between 17.5 and 40 kg/m2, weigh over 50 kg, and are on steady medications for their condition. It's not open to those with conditions affecting drug absorption, neurological disorders (except stable peripheral neuropathy), hepatic carcinoma, hepatorenal syndrome or acute ongoing liver issues.
What is being tested?
The study tests how the body processes fosmanogepix in patients with different stages of liver disease. Participants will take one dose orally and undergo blood sampling to see how the drug is metabolized and cleared from the body over a period of up to 9 weeks.
What are the potential side effects?
Potential side effects aren't specified here but monitoring during physical exams and tests throughout the study will help determine if fosmanogepix is safe for individuals with varying degrees of liver dysfunction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: Fosmanogepix Participants with normal hepatic function (control group)Experimental Treatment1 Intervention
Participants with normal hepatic function will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.
Group II: Cohort 3: Fosmanogepix Participants with severe hepatic impairmentExperimental Treatment1 Intervention
Participants with severe hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.
Group III: Cohort 2: Fosmanogepix Participants with moderate hepatic impairmentExperimental Treatment1 Intervention
Participants with moderate hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.
Group IV: Cohort 1: Fosmanogepix participants with mild hepatic impairmentExperimental Treatment1 Intervention
Participants with mild hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Basilea PharmaceuticaLead Sponsor
51 Previous Clinical Trials
9,883 Total Patients Enrolled
PfizerLead Sponsor
4,649 Previous Clinical Trials
17,744,352 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,536 Previous Clinical Trials
14,915,540 Total Patients Enrolled

Media Library

Fosmanogepix (Antifungal Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05582187 — Phase 1
Liver disease Research Study Groups: Cohort 4: Fosmanogepix Participants with normal hepatic function (control group), Cohort 1: Fosmanogepix participants with mild hepatic impairment, Cohort 2: Fosmanogepix Participants with moderate hepatic impairment, Cohort 3: Fosmanogepix Participants with severe hepatic impairment
Liver disease Clinical Trial 2023: Fosmanogepix Highlights & Side Effects. Trial Name: NCT05582187 — Phase 1
Fosmanogepix (Antifungal Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05582187 — Phase 1
~1 spots leftby Dec 2024