A Phase 1, Open-label, Single-dose, Parallel Cohort Study to Assess the Pharmacokinetics and Safety of Fosmanogepix (PF 07842805) in Adult Participants With Varying Degrees of Hepatic Impairment
Sponsor study identifier
interventional
28
1 country
2
Study Start
October 31, 2022
Actual (reported)Primary Completion
October 16, 2025
Actual (reported)Study Completion
October 16, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 16, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 12, 2022
Actual (reported)October 17, 2022
Actual (reported)October 31, 2022
Actual (reported)October 16, 2025
Actual (reported)October 16, 2025
Actual (reported)Maximum Observed Plasma Concentration (Cmax) of manogepix
pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of manogepix
pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of manogepix
pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Unbound Maximum Observed Plasma Concentration (Cmaxu) of manogepix
pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Number of Participants Reporting Treatment-emergent adverse events (AEs)
Screening to follow-up (Day 28-35)
Number of participants with clinically significant change from baseline in vital signs
From Day -1 to Day 11
Number of participants with clinically significant change from baseline in laboratory parameters
From Day -1 to Day 11
Number of participants with clinically significant change from baseline in electrocardiogram (ECG) findings
From Day -1 to Day 11
Participants with mild hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.
Participants with moderate hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.
a single dose of fosmanogepix administered by mouth under fasted conditions
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Inland Empire Liver Foundation
Rialto, California, 92337, United States
Genesis Clinical Research, LLC
Tampa, Florida, 33603, United States
28 participants (actual enrollment reported by the registry).
First Submitted
October 12, 2022
First Posted
October 17, 2022
Study Start
October 31, 2022
Actual (reported)Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu) of manogepix
pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u] of manogepix
pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Participants with severe hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.
Participants with normal hepatic function will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.
Participants with severe hepatic impairment will receive a single dose of fosmanogepix, administered orally as 2 fosmanogepix tablets under fasted conditions.
Contact the study team to confirm eligibility.
Primary Completion
October 16, 2025
Actual (reported)Study Completion
October 16, 2025
Actual (reported)Last Updated
December 19, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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