A Clinical Trial of the Study Medicine (Called Fosmanogepix) in People With Hepatic Dysfunction.

Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05582187
• Other study ID #: C4791019
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 31, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Basilea Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to understand how fosmanogepix is processed in people with varying degrees of liver dysfunction.

This study is seeking participants who have:

• stable loss of liver function with mild, moderate, or advanced severity

• none of underlying conditions possibly affecting the study medicine being absorbed by the body

• liver dysfunction not due to acute worsening of liver

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) of 17.5 to 40.0 kg/m2, inclusive; and a total body weight greater than 50 kg (greater than 110 lb)

• 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

• 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);

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Fosmanogepix
a single dose of fosmanogepix administered by mouth under fasted conditions

Locations

Country	Name	City	State
United States	Genesis Clinical Research, LLC	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Basilea Pharmaceutica

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of manogepix		pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Primary	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
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of manogepix		pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Primary	Unbound Maximum Observed Plasma Concentration (Cmaxu) of manogepix		pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Primary	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
Primary	Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)u] of manogepix		pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Secondary	Number of Participants Reporting Treatment-emergent adverse events (AEs)		Screening to follow-up (Day 28-35)
Secondary	Number of participants with clinically significant change from baseline in vital signs		From Day -1 to Day 11
Secondary	Number of participants with clinically significant change from baseline in laboratory parameters		From Day -1 to Day 11
Secondary	Number of participants with clinically significant change from baseline in physical exams		From Day -1 to Day 11
Secondary	Number of participants with clinically significant change from baseline in electrocardiogram (ECG) findings		From Day -1 to Day 11