CGRP Receptor Antagonist Formulations for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests different versions of a medicine called a CGRP receptor antagonist to help researchers understand how these versions are absorbed and processed in the body. It targets healthy adults who meet specific criteria, such as having a body weight over 45 kg and a BMI between 16 and 32 kg/m². Participants will help determine if the different formulations of the medicine function similarly in the body. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the original CGRP receptor blocker, such as rimegepant, is usually well-tolerated. Studies have not identified any major safety issues, although some individuals experienced higher levels of the liver enzyme serum alanine. This increase was observed but not linked to serious health problems.
For the new version, BHV-3000, animal studies suggest safety for humans. However, past concerns about liver health with some CGRP blockers mean liver function will be closely monitored in these studies.
Both versions are being tested in healthy adults to assess absorption and processing by the body. As this trial is in an early stage, the main focus is on understanding drug metabolism and ensuring safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about CGRP receptor antagonist formulations because they represent a new way to tackle migraine prevention. Unlike traditional migraine treatments that focus on relieving symptoms after they start, CGRP receptor antagonists work by blocking the protein linked to migraine attacks before they happen. This approach not only has the potential to prevent migraines altogether but also to reduce the frequency and severity of attacks. Additionally, these formulations might offer fewer side effects compared to existing options, making them a promising alternative for many patients.
What evidence suggests that this trial's treatments could be effective?
Research has shown that CGRP receptor blockers, like the formulations studied in this trial, effectively treat migraines. These medications prevent migraines by blocking a protein called CGRP, which plays a key role in causing migraine pain. For example, atogepant, a type of CGRP blocker, reduced the frequency of migraines. Similarly, rimegepant, another CGRP blocker, effectively treats sudden migraine attacks. Both treatments are generally safe and increasingly used to prevent and relieve migraines.678910
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for healthy adults over 18 years old with a BMI of 16-32 kg/m2 and weighing more than 45 kg. Participants must be able to follow the study schedule and procedures.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 two different formulations of a CGRP receptor antagonist to assess bioequivalence
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Reference formulation
- Test formulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University