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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had certain surgeries that may affect how the drug is absorbed in your body.You have a history of ongoing neurological disorders like abnormal movements or seizures, unless you have a stable history of peripheral neuropathy.You have liver cancer or a condition called hepatorenal syndrome, or your doctor doesn't expect you to live much longer.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 4: Fosmanogepix Participants with normal hepatic function (control group)
- Group 2: Cohort 1: Fosmanogepix participants with mild hepatic impairment
- Group 3: Cohort 2: Fosmanogepix Participants with moderate hepatic impairment
- Group 4: Cohort 3: Fosmanogepix Participants with severe hepatic impairment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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