How the body handles fosmanogepix in adults on dialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study examines the pharmacokinetics of intravenous fosmanogepix and its active form, manogepix, in adults with ESRD on intermittent hemodialysis versus those with normal kidney function. It also evaluates how hemodialysis affects drug levels and whether the treatment is safe and tolerable in both groups. Participants may undergo up to two study periods over about 11 weeks, with careful monitoring and standardized procedures. The investigational drug has not been approved by regulatory authorities and its safety in this population is being explored.

Why it matters

Who can join: the full rules

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

Where it's running

• Orlando Clinical Research Center
  Orlando, Florida, United States Recruiting
• Genesis Clinical Research
  Tampa, Florida, United States Recruiting

Study contacts

• Study coordinator: Thomas Kaindl, MD
• Email: thomas.kaindl@basilea.com
• Phone: +41615671505

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.