RecruitingNCT07881224Updated Oct 19, 2026

A Multiple-dose Study Investigating the Drug-drug Interaction Potential and QTc Effects of Fosmanogepix in Healthy Adult Subjects

A Phase 1 interventional study of Fosmanogepix and Placebo in Healthy Adult Participants, sponsored by Basilea Pharmaceutica. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Basilea Pharmaceutica · Phase 1, Interventional, and Other

Updated Oct 19, 2026Newly registeredGo to Updates ↓

Phase: Phase 1
Study type: Interventional
Enrollment: 42
Allocation: Non-randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

This is a Phase 1, fixed-sequence, multiple-dose study in approximately 42 healthy adult participants. The study will be conducted in two parts. Part 1 will evaluate the effect of fosmanogepix, through exposure to its active moiety manogepix, on selected CYP enzymes and on the concentration-QT interval corrected for heart rate (QTc). Part 2 will evaluate the effect of manogepix on CYP2C8 and on selected drug transporters. The maximum study duration will be approximately 13.5 weeks for participants in Part 1 and approximately 12 weeks for participants in Part 2.

Conditions studied

Healthy Adult Participants

Keywords

Drug-drug interaction study
Pharmacokinetics
Healthy adults
Fosmanogepix
Manogepix

In context

Lead sponsor

Basilea Pharmaceutica is the lead sponsor of 59 studies on the registry; 6 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.

Browse Basilea Pharmaceutica studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Body mass index of 18 to 30 kg/m2, inclusive, and a total body weight > 50 kg at screening
Healthy, as determined by medical history, physical examination, and other procedures, including blood pressure and pulse rate, 12-lead ECG, clinical laboratory tests (hematology, clinical chemistry, coagulation, urinalysis), and an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73m2 (CKD-EPI formula), at Screening and Day -2.
Women of childbearing potential must agree to use highly effective forms of contraception during treatment and observation.

Exclusion criteria

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
Active infection.
Any condition possibly affecting drug absorption.
History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb, HCVAb, and syphilis
Subjects who are pregnant, breastfeeding, or plan to become pregnant during the study.

Medical history of neurological disorders, including abnormal movements or seizures.

Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the Investigator's judgment, make the subject inappropriate for the study.
History of allergy or hypersensitivity or other contraindication to any of the drugs to be administered, or to one of the components of the study drugs, as determined by the Investigator.
History of risk factors for QT prolongation, Torsades de Pointes, or uncorrected hypokalemia/hypomagnesemia.
Previous administration of an investigational drug (including a vaccine) within 60 days or five half-lives (whichever is longer) prior to the first study drug administration on Day 1.
For Part 1 only, poor metabolizers of CYP2D6 (*4/*4; *4/*5; *5/*5), CYP2C9 (*2/*2; *2/*3; *3/*3), and/or CYP2C19 (*2/*2) (determined at Screening or from available historical data).
Supine systolic blood pressure (SBP) > 140 mmHg or diastolic blood pressure (DBP) > 90 mmHg, and pulse rate > 100 beats per minute (bpm) or \< 40 bpm Supine 12-lead ECG demonstrating any of the following clinically-relevant abnormalities that may affect subject safety or interpretation of the study results: QTcF interval > 450 msec, QRS interval > 120 msec, complete left bundle branch block, signs of an acute or indeterminate-age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias
Subjects with AST or ALT > 1.0 × ULN.
Blood (excluding plasma) donation or blood loss > 500 mL within 60 days prior to Screening.
History of alcohol abuse or binge drinking and/or any other illicit drug abuse or dependence.
Use of tobacco or nicotine-containing products or devices within 3 months of Screening.
Caffeine consumption ≥ 800 mg per day at Screening.
Use of prescription/non-prescription (including vaccines) drugs or dietary/herbal supplements within 21 days (or five half-lives, whichever is longer) prior to Day -2, except for hormonal contraceptives, or paracetamol up to 1,500 mg/day.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 42 participants (estimated)

Study arms

Experimental
Part 1
Fosmanogepix or placebo + probe substrate cocktail Participants will receive study intervention as follows: * Day 1 and Day 22: probe substrate cocktail * Days 5 to 24: Placebo or fosmanogepix
Drug: Fosmanogepix · Other: Placebo · Other: The medicine cocktail (caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan and midazolam)
Experimental
Part 2
Fosmanogepix + Probe substrates Participants will receive study intervention as follows: * Day 1 and Day 19: Repaglinide * Day 2 and Day 20: Rosuvastatin and Digoxin * Days 6 to 21: Fosmanogepix
Drug: Fosmanogepix · Other: Probe substrates (repaglinide, rosuvastatin, and digoxin)

Interventions

DrugFosmanogepix
Fosmanogepix will be administered as an intravenous infusion or as an oral tablet
OtherPlacebo
Placebo will be administered as an intravenous infusion or as an oral tablet
OtherThe medicine cocktail (caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan and midazolam)
The medicine cocktail will be administered as tablet, capsule, or drink to be swallowed
OtherProbe substrates (repaglinide, rosuvastatin, and digoxin)
Probe substrates will be administered as oral tablets

What researchers measure

Primary outcomes

Part 1: Maximum Plasma Concentration (Cmax) of the medicine cocktail when administered alone or in combination with manogepix at steady state
The effect of fosmanogepix will be checked by comparing the blood levels of the medicine cocktail when taken alone or after administration of fosmanogepix.
Time frame: At Day 1 and Day 22
Part 1: Area under the concentration-time curve (AUC) of the medicine cocktail when administered alone or in combination with manogepix at steady state
The effect of fosmanogepix will be checked by comparing the blood levels of the medicine cocktail when taken alone or after administration of fosmanogepix.
Time frame: At Day 1 and Day 22
Part 2: Maximum Plasma Concentration (Cmax) of probe substrate cocktail when administered alone or in combination with manogepix at steady state
The effect of fosmanogepix will be checked by comparing the blood levels of probe substrate cocktail when taken alone or after administration of fosmanogepix.
Time frame: From Day 1 to Day 20
Part 2: Area under the concentration-time curve (AUC) of probe substrate cocktail when administered alone or in combination with manogepix at steady state
The effect of fosmanogepix will be checked by comparing the blood levels of of probe substrate cocktail when taken alone or after administration of fosmanogepix.
Time frame: From Day 1 to Day 20

Secondary outcomes

Part 1: Placebo-corrected change from baseline in the heart-rate corrected QT interval using Fridericia's formula
Electrocardiogram (ECG) monitoring will be performed during placebo and fosmanogepix administration.
Time frame: From Day 5 to Day 12
Number of participants reporting treatment emergent adverse events (TEAEs)
To evaluate the safety and tolerability of fosmanogepix when administered in combination with the medicine cocktail or probe substrates cocktail
Time frame: From screening to week 13.5

Study locations

1 of 1 sites recruiting

ICON Early Clinical & Bioanalytical Solutions
Groningen, Netherlands 9728 NZ, Netherlands
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Started Oct 2026 (actual). Primary completion is estimated for Mar 2027, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 12, 2026
First posted: Oct 19, 2026
StartActual: Oct 1, 2026
Primary completionEst.: Mar 9, 2027
CompletionEst.: Mar 9, 2027
Last update: Oct 19, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 19, 2026

Show all 1 update

Oct 19, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07881224
Lead sponsor: Basilea Pharmaceutica
Collaborators: Biomedical Advanced Research and Development Authority
Responsible party: Sponsor
First posted: Oct 19, 2026
Start date: Oct 1, 2026
Primary completion: Mar 9, 2027 (estimated)
Completion: Mar 9, 2027 (estimated)
Last update: Oct 19, 2026

Study contacts

Thomas Kaindl, MD

Contact

thomas.kaindl@basilea.com

+41615671505

Thomas Kaindl, MD

study director · Basilea Pharmaceutica International Ltd, Allschwil

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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