Back to resultsA Clinical Trial of the Study Medicine (Called Fosmanogepix) in People With Hepatic Dysfunction.
Primary Purpose
Hepatic Impairment
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fosmanogepix
Sponsored by
About this trial
This is an interventional basic science trial for Hepatic Impairment focused on measuring fosmanogepix, manogepix, hepatic impairment, PF-07842805, APX001, APX001a
Eligibility 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);
Sites / Locations
- Genesis Clinical Research, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1: Fosmanogepix participants with mild hepatic impairment
Cohort 2: Fosmanogepix Participants with moderate hepatic impairment
Cohort 3: Fosmanogepix Participants with severe hepatic impairment
Arm Description
Participants with mild hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.
Participants with moderate hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.
Participants with severe hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.
Outcomes
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) of manogepix
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of manogepix
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of manogepix
Unbound Maximum Observed Plasma Concentration (Cmaxu) of manogepix
Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu) of manogepix
Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u] of manogepix
Secondary Outcome Measures
Number of Participants Reporting Treatment-emergent adverse events (AEs)
Number of participants with clinically significant change from baseline in vital signs
Number of participants with clinically significant change from baseline in laboratory parameters
Number of participants with clinically significant change from baseline in physical exams
Number of participants with clinically significant change from baseline in electrocardiogram (ECG) findings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05582187
Brief Title
A Clinical Trial of the Study Medicine (Called Fosmanogepix) in People With Hepatic Dysfunction.
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
December 17, 2023 (Anticipated)
Study Completion Date
December 17, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
Keywords
fosmanogepix, manogepix, hepatic impairment, PF-07842805, APX001, APX001a
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This is an open label, single dose, parallel cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: Fosmanogepix participants with mild hepatic impairment
Arm Type
Experimental
Arm Description
Participants with mild hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.
Arm Title
Cohort 2: Fosmanogepix Participants with moderate hepatic impairment
Arm Type
Experimental
Arm Description
Participants with moderate hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.
Arm Title
Cohort 3: Fosmanogepix Participants with severe hepatic impairment
Arm Type
Experimental
Arm Description
Participants with severe hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.
Intervention Type
Drug
Intervention Name(s)
Fosmanogepix
Other Intervention Name(s)
PF-07842805
Intervention Description
a single dose of fosmanogepix administered by mouth under fasted conditions
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of manogepix
Time Frame
pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of manogepix
Time Frame
pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of manogepix
Time Frame
pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Title
Unbound Maximum Observed Plasma Concentration (Cmaxu) of manogepix
Time Frame
pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Title
Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu) of manogepix
Time Frame
pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Title
Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u] of manogepix
Time Frame
pre-dose, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96, 168, 240 hours postdose
Secondary Outcome Measure Information:
Title
Number of Participants Reporting Treatment-emergent adverse events (AEs)
Time Frame
Screening to follow-up (Day 28-35)
Title
Number of participants with clinically significant change from baseline in vital signs
Time Frame
From Day -1 to Day 11
Title
Number of participants with clinically significant change from baseline in laboratory parameters
Time Frame
From Day -1 to Day 11
Title
Number of participants with clinically significant change from baseline in physical exams
Time Frame
From Day -1 to Day 11
Title
Number of participants with clinically significant change from baseline in electrocardiogram (ECG) findings
Time Frame
From Day -1 to Day 11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Genesis Clinical Research, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4791019
Description
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A Clinical Trial of the Study Medicine (Called Fosmanogepix) in People With Hepatic Dysfunction.
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