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

• Status: Not yet recruiting
• Trial end date: 2023-12-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

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);