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Antifungal Agent
Fosmanogepix for Liver Disease
Phase 1
Waitlist Available
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 pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 ~ pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of manogepix
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of manogepix
Maximum Observed Plasma Concentration (Cmax) of manogepix
+3 moreSecondary outcome measures
Therapeutic procedure
Electrocardiogram
Number of participants with clinically significant change from baseline in laboratory parameters
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: 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 II: 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 III: 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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Who is running the clinical trial?
Basilea PharmaceuticaLead Sponsor
40 Previous Clinical Trials
9,057 Total Patients Enrolled
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,855 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,093,023 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 1: Fosmanogepix participants with mild hepatic impairment
- Group 2: Cohort 2: Fosmanogepix Participants with moderate hepatic impairment
- Group 3: 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I become an eligible participant in this trial?
"This medical study is looking to include 18 participants aged between 18 and 75 that are struggling with a current hepatic impairment. As well as this, potential members must have a BMI range of 17.5-40 kg/m2, more than 50kg in body weight and have had no major changes to their condition over the last 28 days before screening. Furthermore, any concomitant medications for managing individual health histories must be stable prior to enrolment."
Answered by AI
Is this research project accessible to volunteers at the moment?
"The study detailed on clinicaltrials.gov is no longer actively recruiting, having been initially posted on October 28th 2022 and last updated 12 days after that date. However, there are currently 259 other trials seeking participants."
Answered by AI
Does this clinical trial encompass participants aged 40 or older?
"This study is enrolling individuals between the ages of 18 and 75; however, there are separate studies for children under 18 (27) and adults over 65 (223)."
Answered by AI
Could you elucidate the risks associated with Cohort 1: Fosmanogepix participants who have light hepatic impairment?
"Our evaluation of Cohort 1: Fosmanogepix participants with mild hepatic impairment found safety to be a score of 1 due to the limited amount of data available on efficacy and safety from Phase 1 trials."
Answered by AI
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