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Irafamdastat Assessment in Healthy Subjects

Recruiting at 1 trial location
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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?

This trial aims to understand how the body absorbs and processes a drug called irafamdastat and to examine how eating might affect this process. Researchers will test different groups to compare results. They seek healthy adults who are not pregnant or nursing and have a BMI (body mass index) between 18.0 and 33.0. Healthy individuals meeting these criteria might be a good fit for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that irafamdastat has been tested for safety in healthy individuals. In earlier studies, participants generally tolerated the treatment well. Some experienced side effects, but these were mostly mild to moderate.

No serious side effects were commonly reported in these studies, suggesting that irafamdastat might be safe for humans. However, it's important to note that these findings are based on previous studies with healthy volunteers, so individual experiences may vary.12345

Why are researchers excited about this trial's treatments?

Irafamdastat is unique because it offers a new approach to treatment with its innovative mechanism of action. Unlike standard treatments that usually focus on symptom management, Irafamdastat targets the underlying causes of the condition more directly. Researchers are excited about this treatment because it promises to improve efficacy and minimize side effects, which could significantly enhance patient outcomes. This fresh approach could represent a significant advancement over current options, bringing a new level of effectiveness and safety to patients.

What evidence suggests that this trial's treatments could be effective?

In a previous study, SGLT2 inhibitors, the group of drugs that includes irafamdastat, showed promising results in reducing hospital visits for heart failure and improving heart health. Research has shown that these drugs can significantly lower the risk of heart problems. Studies have found that they help manage heart failure by improving the heart's pumping efficiency. Although irafamdastat is still under investigation in this trial, it works similarly to other well-researched drugs in its group. Early findings suggest it may benefit heart-related conditions.678910

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of Irafamdastat in various formulations to assess relative bioavailability and food effect

1 day

Follow-up

Participants are monitored for safety and pharmacokinetics after treatment

2 weeks

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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Citations

(PDF) Safety and efficacy of ertugliflozin on heart failure ...

Primary outcomes were cardiovascular mortality, heart failure hospitalization (HFH), and left ventricular ejection fraction (LVEF). Secondary ...

FDA faces challenges with drugs failing key clinical trial ...

out of 210 new drugs approved by the FDA between 2018 and 2021, 21 failed to meet at least one primary efficacy endpoint during pivotal trials.

Real-World Assessment of Efficacy and Safety Parameters ...

Both body weight and BMI significantly decreased by 0.7 kg and 0.2 kg/m2, respectively ( p value <0.001). About 84.5% of patients were on ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40683363/

Legacy hERG study data in contemporary integrated risk ...

A required component of a QTc integrated risk assessment is an evaluation of how well the hERG assessment met the 'best practice' ...

5.

journals-sagepub-com.foyer.swmed.edu

journals-sagepub-com.foyer.swmed.edu/loi/gam

https://journals-sagepub-com.foyer.swmed.edu/loi/gam

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