A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05582187

Enrollment

Registered

2022-10-17

Start date

2022-10-31

Completion date

2025-10-16

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Keywords

fosmanogepix, manogepix, hepatic impairment, PF-07842805, APX001, APX001a

Brief summary

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.

Interventions

DRUGFosmanogepix

a single dose of fosmanogepix administered by mouth under fasted conditions

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

This is an open label, single dose, parallel cohort study

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * Body mass index (BMI) of 17.5 to 40.0 kg/m2 (42 kg/m2 for participants of Cohort 3), inclusive; and a total body weight greater than 50 kg (greater than 110 lb) * For participants with hepatic impairment (Cohorts 1-3, and Cohort 5): Stable hepatic impairment that meets the criteria for Class A, B, or C of the Child Pugh classification with no clinically significant change in disease status within the 28 days prior to the screening visit * For participants with normal hepatic function (Cohort 4): No clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests * Stable concomitant medications for the management of individual participants' medical history Key

Exclusion criteria

* Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection); * Ongoing medical history of neurological disorders including abnormal movements or seizures (Note exception: stable history of peripheral neuropathy); * Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy; * A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or MRI; * Signs of clinically active Grade 2, 3 or 4 hepatic encephalopathy (ie, equal or greater than Grade 2 Portal Systemic Encephalopathy score)

Design outcomes

Primary

Measure	Time frame
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
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
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
Maximum Observed Plasma Concentration (Cmax) of manogepix	pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose

Secondary

Measure	Time frame
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
Number of Participants Reporting Treatment-emergent adverse events (AEs)	Screening to follow-up (Day 28-35)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026