A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.
- Registration Number
- NCT05582187
- Lead Sponsor
- Basilea Pharmaceutica
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
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): 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3: Fosmanogepix Participants with severe hepatic impairment Fosmanogepix Participants with severe hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions. Cohort 4: Fosmanogepix Participants with normal hepatic function (control group) Fosmanogepix Participants with normal hepatic function will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions. Cohort 1: Fosmanogepix participants with mild hepatic impairment Fosmanogepix Participants with mild hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions. Cohort 2: Fosmanogepix Participants with moderate hepatic impairment Fosmanogepix Participants with moderate hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.
- Primary Outcome Measures
Name Time Method 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 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 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
- Secondary Outcome Measures
Name Time Method 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 electrocardiogram (ECG) findings From Day -1 to Day 11
Trial Locations
- Locations (2)
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Genesis Clinical Research, LLC
🇺🇸Tampa, Florida, United States