Evaluating the effects of fosmanogepix in patients with liver impairment

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

This study is testing how well the antifungal medication fosmanogepix works and is processed in people with liver problems to ensure it's safe for them.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Basilea Pharmaceutica (Industry-sponsored)
• Locations: 2 sites (Rialto, California and 1 other locations)
• Trial ID: NCT05582187 on ClinicalTrials.gov

What this trial studies

This open-label clinical trial aims to assess the pharmacokinetics of fosmanogepix, an antifungal medication, in participants with varying degrees of hepatic function. Participants will receive a single oral dose of the medication, and blood samples will be collected to analyze how the drug is processed and eliminated by the body. The study will also include physical examinations and other tests to evaluate the safety of fosmanogepix. The duration of participation will range from 4 to 9 weeks, with multiple visits to the study clinic.

Who should consider this trial

Good fit: Ideal candidates include individuals with stable hepatic impairment classified as Class A, B, or C according to the Child Pugh classification, as well as those with normal hepatic function.

Not a fit: Patients with conditions affecting drug absorption or ongoing neurological disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safe use of fosmanogepix in patients with liver impairment.

How similar studies have performed: While this approach is focused on a specific patient population, similar studies evaluating pharmacokinetics in patients with hepatic impairment have shown promise.

Eligibility 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): 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)

Where this trial is running

Rialto, California and 1 other locations

• Inland Empire Liver Foundation — Rialto, California, United States (Recruiting)
• Genesis Clinical Research, LLC — Tampa, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Thomas Kaindl, MD

Conditions Hepatic Impairment; fosmanogepix; manogepix; hepatic impairment; PF-07842805; APX001; APX001a