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Irafamdastat Assessment in Healthy Subjects

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Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Celgene
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for healthy adults who do not have significant medical conditions. Participants should not be taking medications or have any health issues that could affect the study results.

Inclusion Criteria

I am healthy and either male or not pregnant or nursing.
BMI between 18.0 and 33.0 kg/m2, inclusive

Exclusion Criteria

I do not have major organ problems or abnormal test results beyond what is expected.
Other protocol-defined Inclusion/Exclusion criteria apply

What Are the Treatments Tested in This Trial?

Interventions

  • Irafamdastat

Trial Overview

The study is testing how much of the drug irafamdastat gets into the body and whether eating food changes this, using different forms of the medication in healthy volunteers.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: Treatment EExperimental Treatment1 Intervention
Group II: Treatment DExperimental Treatment1 Intervention
Group III: Treatment CExperimental Treatment1 Intervention
Group IV: Treatment BExperimental Treatment1 Intervention
Group V: Treatment AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials
649
Recruited
130,000+
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Jay Backstrom profile image

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

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Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

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