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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Fosmanogepix participants with mild hepatic impairment | Experimental | Participants with mild hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions. |
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| Cohort 2: Fosmanogepix Participants with moderate hepatic impairment | Experimental | Participants with moderate hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions. |
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| Cohort 3: Fosmanogepix Participants with severe hepatic impairment | Experimental | Participants with severe hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions. |
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| Cohort 4: Fosmanogepix Participants with normal hepatic function (control group) | Experimental | Participants with normal hepatic function will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions. |
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| Cohort 5: Fosmanogepix Participants with severe hepatic impairment (new dose level) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fosmanogepix | Drug | a single dose of fosmanogepix administered by mouth under fasted conditions |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inland Empire Liver Foundation | Rialto | California | 92337 | United States | ||
| Genesis Clinical Research, LLC |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 7, 2025 | Dec 8, 2025 | ICF_000.pdf |
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This is an open label, single dose, parallel cohort study
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Participants with severe hepatic impairment will receive a single dose of fosmanogepix, administered orally as 2 fosmanogepix tablets under fasted conditions.
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| 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 electrocardiogram (ECG) findings | From Day -1 to Day 11 |
| Tampa |
| Florida |
| 33603 |
| United States |