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

NCT ID: NCT05582187

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2025-10-16

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.

Conditions

Hepatic Impairment

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cohort 1: Fosmanogepix participants with mild hepatic impairment

Participants with mild hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.

Group Type: EXPERIMENTAL

Fosmanogepix

Intervention Type: DRUG

a single dose of fosmanogepix administered by mouth under fasted conditions

Cohort 2: Fosmanogepix Participants with moderate hepatic impairment

Participants with moderate hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.

Group Type: EXPERIMENTAL

Fosmanogepix

Intervention Type: DRUG

a single dose of fosmanogepix administered by mouth under fasted conditions

Cohort 3: Fosmanogepix Participants with severe hepatic impairment

Participants with severe hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.

Group Type: EXPERIMENTAL

Fosmanogepix

Intervention Type: DRUG

a single dose of fosmanogepix administered by mouth under fasted conditions

Cohort 4: Fosmanogepix Participants with normal hepatic function (control group)

Participants with normal hepatic function will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.

Group Type: EXPERIMENTAL

Fosmanogepix

Intervention Type: DRUG

a single dose of fosmanogepix administered by mouth under fasted conditions

Cohort 5: Fosmanogepix Participants with severe hepatic impairment (new dose level)

Participants with severe hepatic impairment will receive a single dose of fosmanogepix, administered orally as 2 fosmanogepix tablets under fasted conditions.

Group Type: EXPERIMENTAL

Fosmanogepix

Intervention Type: DRUG

a single dose of fosmanogepix administered by mouth under fasted conditions

Interventions

Fosmanogepix

a single dose of fosmanogepix administered by mouth under fasted conditions

Intervention Type: DRUG

Eligibility Criteria

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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biomedical Advanced Research and Development Authority

FED

Sponsor Role: collaborator

Basilea Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Inland Empire Liver Foundation

Rialto, California, United States

Genesis Clinical Research, LLC

Tampa, Florida, United States

Countries

United States

Other Identifiers

C4791019

Identifier Type: -

Identifier Source: org_study_id