A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis

NCT07916181 · tracked via the Priya Life Science USA tracker

Sponsor

Basilea Pharmaceutica

Phase

Phase 1

Started

2026-10-27

Last updated

2026-11-04

Condition(s) studied

End Stage Renal Disease on DialysisAdult

Investigational drug(s) / intervention(s)

Intravenous fosmanogepix →Intravenous fosmanogepix →

Intravenous fosmanogepix: Two doses of intravenous fosmanogepix will be administered on Day 1 and Day 2.

Intravenous fosmanogepix: Two doses of intravenous fosmanogepix will be administered on Day 1 and Day 2 in each period (Period 1 and 2)

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Accepted

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 pregnant during the study. * Laboratory abnormality or other medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior, that may increase the risk to study participation, or in the Investigator's judgment, make the subject inappropriate for the study. * History or presence of clinically-significant disorders, which, in the opinion of the Investigator, are capable of significantly altering the distribution, metabolism, or elimination of the study drug. * Renal or liver transplant recipients * Hepatic impairment not related to ESRD * Use of any prohibited medication within five half-lives plus 14 days prior to Day -1 Subjects with ESRD requiring IHD only: -Not on stable dosing regimen (i.e., \< 3 weeks prior to Screening) of prescription/ non prescription drugs (including dietary/herbal supplements) for the treatment of a stable concomitant disease

Primary outcome measure(s)

Maximum Plasma Concentration (Cmax) of manogepix — Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
Cmax of manogepix will be assessed in participants with ESRD in Period 2 and compared with that of healthy participants in Period 1.
Area under the concentration-time curve (AUC) of manogepix — Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
AUC of manogepix will be assessed in participants with ESRD in Period 2 and compared with that of healthy participants in Period 1.
Impact of IHD on the AUC of manogepix (total and unbound) in Periods 1 and 2 — Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
Impact of IHD on the AUC of manogepix (total and unbound) in Periods 1 and 2 will be assessed after fosmanogepix IV administration in subjects with ESRD requiring IHD.
Impact of IHD on the Tmax of manogepix (total and unbound) Periods 1 and 2 — Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
Impact of IHD on the Tmax of manogepix (total and unbound) will be assessed in Periods 1 and 2 after fosmanogepix IV administration in subjects with ESRD requiring IHD.
Impact of IHD on the Cmax of manogepix (total and unbound) Periods 1 and 2 — Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
Impact of IHD on the Cmax of manogepix (total and unbound) will be assessed in Periods 1 and 2 after fosmanogepix IV administration in participants with ESRD requiring IHD.

Trial sites (2)

Facility	City	Region	Status
Orlando Clinical Research Center	Orlando	Florida	Recruiting
Genesis Clinical Research	Tampa	Florida	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07916181 on ClinicalTrials.gov ↗ ← All trials in the USA