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.
- Liver Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 5 Secondary · Reporting Duration: pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Cohort 1: Fosmanogepix participants with mild hepatic impairment
1 of 3
Cohort 2: Fosmanogepix Participants with moderate hepatic impairment
1 of 3
Cohort 3: Fosmanogepix Participants with severe hepatic impairment
1 of 3
Experimental Treatment
18 Total Participants · 3 Treatment Groups
Primary Treatment: Cohort 1: Fosmanogepix participants with mild hepatic impairment · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 75 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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)." - Anonymous Online Contributor
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." - Anonymous Online Contributor