Recruiting
Phase 1

Fosmanogepix

Sponsor:

Basilea Pharmaceutica

Code:

NCT07916181

Conditions

End Stage Renal Disease on Dialysis

Adult

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Intravenous fosmanogepix

Intravenous fosmanogepix

Study Details

Brief 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.

Conditions

End Stage Renal Disease on Dialysis

Adult

Study ID

NCT07916181

Start date

Oct 27, 2026

Status verified date

Oct, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Period 1 and Period 2

Participants with end stage renal disease (ESRD) requiring intermittent hemodialysis (IHD)

experimental: Period 1

Participants with normal renal function (control group)

Interventions

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)

Primary outcome measure

  • Maximum Plasma Concentration (Cmax) of manogepix [ Time Frame: 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. ]
  • Area under the concentration-time curve (AUC) of manogepix [ Time Frame: 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 [ Time Frame: 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) Periods 1 and 2 [ Time Frame: 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) Periods 1 and 2 [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Thomas Kaindl, MD

+41615671505thomas.kaindl@basilea.com

Locations

Orlando Clinical Research Center

Recruiting

Orlando, Florida, United States, 32809

Genesis Clinical Research

Recruiting

Tampa, Florida, United States, 33603

More Information

Sponsor

Basilea Pharmaceutica

Last update posted

Nov 4, 2026

Last verified

Oct, 2026

Keywords

  • Pharmacokinetics
  • Fosmanogepix
  • Manogepix
  • Adults
  • ESRD requiring IHD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Basilea Pharmaceutica on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.