Healthy Adult ParticipantsPhase 1NCT07881224
A Multiple-dose Study Investigating the Drug-drug Interaction Potential and QTc Effects of Fosmanogepix in Healthy Adult Subjects
A Phase 1 study testing Fosmanogepix, The medicine cocktail (caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan and midazolam) and Probe substrates (repaglinide, rosuvastatin, and digoxin) in people with Healthy Adult Participants, run by Basilea Pharmaceutica at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Fosmanogepix, The medicine cocktail (caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan and midazolam) and Probe substrates (repaglinide, rosuvastatin, and digoxin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2026to 9 Mar 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
ICON Early Clinical & Bioanalytical Solutions
Groningen, Netherlands, 9728 NZ
About this study
Official title: A Phase 1, Non-randomized, Fixed-sequence, Multiple-dose Study Investigating the Drug-drug Interaction Potential and QTc Effects of Fosmanogepix in Healthy Adult Subjects
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
- Healthy Adult Participants
- Being tested
- Fosmanogepix, Placebo, The medicine cocktail (caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan and midazolam), Probe substrates (repaglinide, rosuvastatin, and digoxin)
- Keywords
- Drug-drug interaction study, Pharmacokinetics, Healthy adults, Fosmanogepix, Manogepix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosmanogepixDrug
Fosmanogepix will be administered as an intravenous infusion or as an oral tablet
PlaceboOther
Placebo will be administered as an intravenous infusion or as an oral tablet
The medicine cocktail (caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan and midazolam)Other
The medicine cocktail will be administered as tablet, capsule, or drink to be swallowed
Probe substrates (repaglinide, rosuvastatin, and digoxin)Other
Probe substrates will be administered as oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | 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 Receives: Drug: Fosmanogepix; Other: Placebo; Other: The medicine cocktail (caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan and midazolam) |
| Part 2 | Experimental | 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 Receives: Drug: Fosmanogepix; Other: Probe substrates (repaglinide, rosuvastatin, and digoxin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Day 1 to Day 20
Secondary outcomes (2)
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.
Measured: 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
Measured: From screening to week 13.5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Oct 2026
- Primary completion9 Mar 2027 (estimated)
- Study completion9 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Thomas Kaindl, MD, Study director, Basilea Pharmaceutica International Ltd, Allschwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881224
- Sponsor's protocol ID
- FMGX-CP-110
- Other IDs
- 75A50124C00033, 2026-526076-23-00
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No