PF-08049820 for Atopic Dermatitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how a new medicine, PF-08049820, designed for atopic dermatitis (a skin condition causing itchy, inflamed skin), behaves in the body. Researchers aim to determine how the medicine is absorbed and whether its formulation or consumption with a high-fat meal affects its efficacy. Participants will try five different versions of the medicine, including tablets that release the medicine quickly and slowly. This study suits men and women who are generally healthy, do not have serious medical problems, and can adhere to study rules, including staying at the clinic overnight. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain prescription or nonprescription drugs and dietary or herbal supplements at least 14 days before the study starts. This is to ensure that these substances do not affect how the study medicine works in your body.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that PF-08049820 has been tested in healthy adults to assess its safety. Earlier studies examined how this medicine works in the body and determined safe dosage levels. Participants in these studies used the medicine without major safety problems, and it appears to be generally well-tolerated, with most experiencing no serious side effects.
The current study is in an early phase, focusing on how the body processes the medicine and identifying any potential side effects. Although safety information is limited due to the early phase, no serious issues have been widely reported in the available data.12345Why are researchers excited about this trial's treatments?
Researchers are excited about PF-08049820 for atopic dermatitis because it offers several novel features compared to standard treatments like topical corticosteroids and calcineurin inhibitors. Unlike these conventional options, PF-08049820 utilizes a modified release (MR) tablet format, which may improve how the medication is absorbed and utilized in the body. With both short and long MR formulations being tested, there's potential for customizing treatment to better manage symptoms under different conditions, such as whether the patient has eaten. Additionally, the immediate release (IR) version offers rapid delivery, potentially providing faster relief. This range of delivery options could lead to more personalized and effective treatment strategies for atopic dermatitis.
What evidence suggests that this trial's treatments could be effective for atopic dermatitis?
Research has shown that PF-08049820 is under study as a treatment for atopic dermatitis, also known as eczema. In this trial, participants will receive different formulations of PF-08049820, including Immediate Release (IR) and Modified Release (MR1 and MR2) tablets, under various conditions. Studies with patients who have moderate to severe eczema have shown that this treatment can reduce symptoms. The medicine targets specific parts of the immune system believed to cause skin inflammation and irritation. Early results from these studies suggest that PF-08049820 can help manage the condition by calming the skin's immune response. While more information is needed, initial findings are encouraging for people with this skin condition.12345
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 who are at least 18 years old, weigh over 99 pounds, and have a body weight that's neither too low nor too high. Participants must be unable to have children and should not have serious medical conditions, recent drug use or certain vaccines. They need to commit to the study rules.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 5 different versions of the medicine, with 3 days between each dose, to study pharmacokinetics under fasted and fed conditions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PF-08049820 IR
- PF-08049820 MR1
- PF-08049820 MR2
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