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NCT07879170

A Single and Multiple Ascending Dose Study of EPX-100 in Healthy Adult Participants

StatusRecruiting
PhasePhase 1
SponsorEpygenix
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Number of Participants with Treatment Emergent Adverse Events (TEAEs) in Part 1 SAD
Timeframe: Part 1 SAD: up to Day 18
Number of Participants with TEAEs in Part 2 MAD
Timeframe: Part 2 MAD: up to Day 31

Secondary (5)

Area Under the concentration-time curve (AUC), From Time 0 to The Last Observed Nonzero Concentration (AUC0-last) of EPX-100 and Metabolites in Plasma
AUC0-last of EPX-100 and Metabolites in Urine
Maximum Observed Concentration (Cmax) of EPX-100 and Metabolites in Plasma
Cmax of EPX-100 and Metabolites in Urine
Change from Baseline in Electrocardiogram (ECG) QT Interval Corrected According to the Method of Fridericia (QTcF)

Arms and interventions

Part 1 SAD: EPX-100Experimental

Sequential cohorts of participants will receive a single ascending dose of EPX-100.

Part 1 SAD: PlaceboPlacebo comparator

Participants will receive a single dose of EPX-100-matching placebo.

Part 2 MAD: Treatment ArmExperimental

Participants will receive EPX-100 twice daily on Days 1 to 13, and a morning dose of EPX-100 on Day 14. Moxifloxacin-matching placebo will be administrated on Days 1 and 15. Participants will also receive a single dose of EPX-100-matching placebo on the morning of Days -1 and 15.

Part 2 MAD: Control ArmActive comparator

Participants will receive moxifloxacin or moxifloxacin-matching placebo on the morning of Day 1 then will cross over to the alternate treatment on the morning of Day 15. EPX-100-matching placebo will be administered twice daily on Days 1 to 13 with a morning dose on Day 14. Participants will also receive a single dose of EPX-100-matching placebo on the morning of Days -1 and 15.

Drugs: EPX-100, EPX-100-Matching Placebo, Moxifloxacin, Moxifloxacin-Matching Placebo

Sites

1 site in 1 country

  • CelerionTempe, Arizona, United States