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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
a single dose of fosmanogepix administered by mouth under fasted conditions
Inland Empire Liver Foundation
Rialto, California, United States
Genesis Clinical Research, LLC
Tampa, Florida, United States
Maximum Observed Plasma Concentration (Cmax) of manogepix
Time frame: 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
Time frame: 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
Time frame: pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Unbound Maximum Observed Plasma Concentration (Cmaxu) of manogepix
Time frame: 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 Last Quantifiable Concentration (AUClastu) of manogepix
Time frame: 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
Time frame: 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)
Time frame: Screening to follow-up (Day 28-35)
Number of participants with clinically significant change from baseline in vital signs
Time frame: From Day -1 to Day 11
Number of participants with clinically significant change from baseline in laboratory parameters
Time frame: From Day -1 to Day 11
Number of participants with clinically significant change from baseline in electrocardiogram (ECG) findings
Time frame: From Day -1 to Day 11
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