To evaluate the effect of IPI-145 on the pharmacokinetics of midazolam, a cytochrome P450 3A (CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with midazolam in healthy subjects.
* In Treatment Period 1, subjects will receive a single 2 mg oral dose of midazolam. * In Treatment Period 2, on Days 2-6, the same subjects will receive twice daily (BID) oral doses of 25 mg IPI-145; on Day 6, subjects will receive the morning dose of 25 mg IPI-145 concomitantly administered with 2 mg of midazolam.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
14
PRA International
Lenexa, Kansas, United States
Pharmacokinetic parameters (AUC) of midazolam and 1-hydroxy-midazolam
Time frame: Over 24 hours
Pharmacokinetic parameters (Cmax) of midazolam and 1-hydroxy-midazolam
Time frame: Over 24 hours
Pharmacokinetic parameters (t1/2) of midazolam and 1-hydroxy-midazolam
Time frame: Over 24 hours
Plasma concentrations of midazolam and 1-hydroxy-midazolam
Time frame: Over 24 hours
Incidence of adverse events following of administration midazolam, IPI-145 and the combination
Safety Findings
Time frame: 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.