This is a 3-part, drug-drug interaction study in healthy participants. Each part is designed as a 2-period, fixed-sequence and can be conducted concurrently. Part 1 will assess the effect of itraconazole on the pharmacokinetics (PK) of EPX-100. Part 2 will assess the effect of phenytoin on the PK of EPX-100. Part 3 will assess the effect of EPX-100 on the PK of omeprazole, midazolam, and bupropion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
54
Oral solution
Oral solution
Phenytoin sodium extended-release capsules
Celerion
Tempe, Arizona, United States
Area Under The Concentration-time Curve (AUC), from Time 0 to the Last Observed Non-zero Concentration (AUC0-t) Of EPX-100
Time frame: Up to Day 15
AUC From Time 0 extrapolated to infinity (AUC0-inf) of EPX-100
Time frame: Up to Day 15
Maximum Observed Concentration (Cmax) of EPX-100
Time frame: Up to Day 15
AUC0-t of Omeprazole
Time frame: Up to Day 15
AUC0-inf of Omeprazole
Time frame: Up to Day 15
Cmax of Omeprazole
Time frame: Up to Day 15
AUC0-t of Midazolam
Time frame: Up to Day 15
AUC0-inf of Midazolam
Time frame: Up to Day 15
Cmax of Midazolam
Time frame: Up to Day 15
AUC0-t of Bupropion
Time frame: Up to Day 19
AUC0-inf of Bupropion
Time frame: Up to Day 19
Cmax of Bupropion
Time frame: Up to Day 19
Number of Participants with Treatment Emergent Adverse Events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Delayed-release capsule
Midazolam hydrochloride (HCl) syrup
Bupropion HCl tablets
Time frame: Up to 12 Weeks