A Clinical Trial of the Study Medicine (Called Fosmanogepix) in People With Hepatic Dysfunction.
Study Details
Study Description
Brief 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:
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stable loss of liver function with mild, moderate, or advanced severity
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none of underlying conditions possibly affecting the study medicine being absorbed by the body
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Fosmanogepix
a single dose of fosmanogepix administered by mouth under fasted conditions
Other Names:
|
| Experimental: 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. |
Drug: Fosmanogepix
a single dose of fosmanogepix administered by mouth under fasted conditions
Other Names:
|
| Experimental: 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. |
Drug: Fosmanogepix
a single dose of fosmanogepix administered by mouth under fasted conditions
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) 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]
- 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]
Secondary Outcome Measures
- Number of Participants Reporting Treatment-emergent adverse events (AEs) [Screening to follow-up (Day 28-35)]
- 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 physical exams [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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)
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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
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Stable concomitant medications for the management of individual participants' medical history
Exclusion Criteria:
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Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection);
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Ongoing medical history of neurological disorders including abnormal movements or seizures (Note exception: stable history of peripheral neuropathy);
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Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy;
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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;
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Signs of clinically active Grade 2, 3 or 4 hepatic encephalopathy (ie, equal or greater than Grade 2 Portal Systemic Encephalopathy score);
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Genesis Clinical Research, LLC | Tampa | Florida | United States | 33603 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C4791019