Basilea Pharmaceutica
This study will evaluate how fosmanogepix is processed by the body (pharmacokinetics, PK) in participants with kidney failure (end-stage renal disease (ESRD) requiring intermittent hemodialysis (IHD) compared with participants with normal kidney function (control group). Fosmanogepix is given by intravenous infusion and is converted in the body to manogepix, the active form of the drug. Fosmanogepix is an investigational and has not been approved by the United States Food and Drug Administration (FDA) or any other regulatory authority for use in humans. The study will also evaluate the effect of hemodialysis on manogepix levels in participants with ESRD. The safety and tolerability of fosmanogepix will also be assessed in participants with kidney failure and in matched participants with normal kidney function. Participation in the study will last up to 11 weeks and will include up to two study periods. Participants with ESDR requiring IHD will receive fosmanogepix in two study periods. Healthy participants will receive fosmanogepix in one study period. The study will be conducted at two study sites in the United States.
Inclusion Criteria: * Body mass index of 18 to 42 kg/m2, inclusive, and a total body weight \> 50 kg at Screening. * Subjects with normal renal function only: Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min * Subjects with ESRD requiring IHD only: Hemodialysis treatment for at least 3 months prior to Screening, with dialysis performed ≥ 3 times per week and adequate dialysis efficiency as established by document Kt/V ≥ 1.2 on current regimen. The clinical status of the underlying ESRD should be stable Exclusion Criteria: * Subjects who are pregnant, breastfeeding, or plan to become…
Two doses of intravenous fosmanogepix will be administered on Day 1 and Day 2.
Two doses of intravenous fosmanogepix will be administered on Day 1 and Day 2 in each period (Period 1 and 2)