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OpenTrials
Completed

NCT Number: NCT05582187

A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.

The primary purpose of this open-label study is to characterize the plasma pharmacokinetics (PK) of manogepix (active moiety of fosmanogepix) in participants with varying degrees of hepatic function following administration of a single oral dose of fosmanogepix.

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inland Empire Liver Foundation, Rialto, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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, and Cohort 5): 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)

Treatment and study plan

Fosmanogepix

Drug

a single dose of fosmanogepix administered by mouth under fasted conditions

Primary outcomes

  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 outcomes

  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 electrocardiogram (ECG) findings

    Time frame: From Day -1 to Day 11

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2022
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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