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

Phase 1Not Yet RecruitingNCT07837115

Celgene24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

IrafamdastatDRUG

Specified dose on specified days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Local Institution - 0001

Anaheim, California, United States

Outcomes

Primary Outcomes

Maximum observed plasma concentration (Cmax)

Time frame: Up to Day 19

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

Time frame: Up to Day 19

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

Time frame: Up to Day 19

Secondary Outcomes

Time of maximum observed plasma concentration (Tmax)

Time frame: Up to Day 19

Terminal elimination half-life (T-HALF)

Time frame: Up to Day 19

Apparent total body clearance (CLT/F)

Time frame: Up to Day 19

Volume of distribution of terminal phase (Vz/F)

Time frame: Up to Day 19

Number of participants with adverse events (AEs)

Time frame: Up to Day 28 days after last dose

Number of participants with serious AEs (SAEs)

Time frame: Up to Day 28 days after last dose

Number of participants with vital sign abnormalities

Time frame: Up to Day 21

Number of participants with physical examination abnormalities

Time frame: Up to Day 21

Central Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.