The purpose of this study is to evaluate the relative bioavailability of irafamdastat and to assess food-effect on the pharmacokinetics (PK) of irafamdastat ODT in healthy adult participants.
Healthy male or non-pregnant and non-nursing female (as assigned at birth).
BMI between 18.0 and 33.0 kg/m2, inclusive.
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population at screening and Day 1 predose, confirmed by repeat.
Other protocol-defined Inclusion/Exclusion criteria apply
Crossover
Irafamdastat
DrugSpecified dose on specified days.
Maximum observed plasma concentration (Cmax)
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time of maximum observed plasma concentration (Tmax)
Terminal elimination half-life (T-HALF)
Apparent total body clearance (CLT/F)
Volume of distribution of terminal phase (Vz/F)
This trial is not recruiting at the moment. You can still explore other options:
