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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05582187
Recruitment Status : Recruiting
First Posted : October 17, 2022
Last Update Posted : December 15, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: Fosmanogepix Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an open label, single dose, parallel cohort study
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : October 31, 2022
Estimated Primary Completion Date : December 17, 2023
Estimated Study Completion Date : December 17, 2023
Arms and Interventions
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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 Name: PF-07842805
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 Name: PF-07842805
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 Name: PF-07842805


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 Measures :
  1. Number of Participants Reporting Treatment-emergent adverse events (AEs) [ Time Frame: Screening to follow-up (Day 28-35) ]
  2. Number of participants with clinically significant change from baseline in vital signs [ Time Frame: From Day -1 to Day 11 ]
  3. Number of participants with clinically significant change from baseline in laboratory parameters [ Time Frame: From Day -1 to Day 11 ]
  4. Number of participants with clinically significant change from baseline in physical exams [ Time Frame: From Day -1 to Day 11 ]
  5. Number of participants with clinically significant change from baseline in electrocardiogram (ECG) findings [ Time Frame: From Day -1 to Day 11 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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);
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05582187


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, Florida
Genesis Clinical Research, LLC Recruiting
Tampa, Florida, United States, 33603
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05582187    
Other Study ID Numbers: C4791019
First Posted: October 17, 2022    Key Record Dates
Last Update Posted: December 15, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
fosmanogepix
manogepix
hepatic impairment
 PF-07842805
APX001
APX001a
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases