A Phase 1, Open-label, Randomized, Single-dose Study to Assess the Relative Bioavailability of Irafamdastat (BMS-986368) Oral Disintegrating Tablet, Oral Disintegrating Tablet Suspension, and Capsule Sprinkles to the Reference Capsule and to Assess the Food Effect on the Pharmacokinetics of Irafamdastat Administered as Oral Disintegrating Tablet in Healthy Adult Participants

Celgene

Summary

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

Age range: 18–55 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

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

Interventions

Drug
Irafamdastat
Specified dose on specified days.

Location

Local Institution - 0001
Anaheim, California

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions