A Study to Assess the Relative Bioavailability of Irafamdastat (BMS-986368) and to Assess the Food Effect on the Pharmacokinetics of Irafamdastat in Healthy Adult Participants
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Healthy male or non-pregnant and non-nursing female (as assigned at birth).
* BMI between 18.0 and 33.0 kg/m2, inclusive.
Exclusion Criteria:
* 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
Primary outcome measure(s)
Maximum observed plasma concentration (Cmax) — Up to Day 19
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) — Up to Day 19
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) — Up to Day 19
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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