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NCT07837115
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
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 24
Sponsor: Celgene
Location: Local Institution - 0001 Anaheim California
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 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
Source: ClinicalTrials.gov (NCT07837115). StuddyBuddy aggregates publicly available trial information.
