A Multiple-dose Study Investigating the Drug-drug Interaction Potential and QTc Effects of Fosmanogepix in Healthy Adult Subjects
Sponsor: Basilea Pharmaceutica • ClinicalTrials.gov ID: NCT07881224
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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.
Interventions
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Fosmanogepix
(Drug)
Fosmanogepix will be administered as an intravenous infusion or as an oral tablet
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Placebo
(Other)
Placebo will be administered as an intravenous infusion or as an oral tablet
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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
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Probe substrates (repaglinide, rosuvastatin, and digoxin)
(Other)
Probe substrates will be administered as oral tablets
Eligibility criteria
Conditions
Locations
- ICON Early Clinical & Bioanalytical Solutions — Groningen, Netherlands, Netherlands
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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