Irafamdastat Assessment in Healthy Subjects
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of Irafamdastat in various formulations to assess relative bioavailability and food effect
Follow-up
Participants are monitored for safety and pharmacokinetics after treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Celgene
Lead Sponsor
Jay Backstrom
Celgene
Chief Medical Officer since 2016
MD
Mark Alles
Celgene
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania
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 ...
2.
patientdaily.com
patientdaily.com/fda-faces-challenges-with-drugs-failing-key-clinical-trial-benchmarksFDA 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 ...
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' ...
https://journals-sagepub-com.foyer.swmed.edu/loi/gam
No information is available for this page.
Irafamdastat
Irafamdastat is a centrally penetrant dual fatty acid amide hydrolase (FAAH) inhibitor and monoacylglycerol lipase (MAGL) inhibitor which is under ...
7.
medchemexpress.com
medchemexpress.com/irafamdastat.html?srsltid=AYCX9vIu-2L3mdttPZnrBBumTowexv4RAJcL5bV7f6VtvAfT2Ghvg1o8Irafamdastat (BMS-986368) | FAAH/MAGL Inhibitor
Irafamdastat is used in research on Alzheimer's disease, multiple sclerosis, and epilepsy. For research use only. We do not sell to patients. Purity : 98.07% ...
Irafamdastat - Drug Targets, Indications, Patents
... Safety, and Tolerability of BMS-986368 in Healthy Chinese Participants ... Irafamdastat Administered as Oral Disintegrating Tablet in Healthy ...
9.
caymanchem.com
caymanchem.com/product/46389/irafamdastat?srsltid=AYCX9vIlI19tAvDxeGbteWwv2nMJcFaE9sIouZYzTrzDUk101Pw7toOdIrafamdastat (CAS 2244136-58-9)
Irafamdastat is a dual inhibitor of fatty acid amide hydrolase (FAAH) and monoacylglycerol lipase (MAGL). WARNING This product is not for human or veterinary ...
A Study to Assess the Relative Bioavailability of ...
They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is ...
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