24 Participants NeededMy employer runs this trial

PF-08049820 for Healthy Adults

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pfizer
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 study medicine, PF-08049820 (an experimental treatment), is absorbed and eliminated by the body in healthy adults. Researchers seek to determine if taking the medicine with food or with rabeprazole (a medication that lowers stomach acid) affects absorption. Participants will take different forms of PF-08049820 either with or without food and, in some cases, alongside rabeprazole. The trial seeks healthy adults with a body mass index (BMI) between 16 and 32, weighing more than 110 pounds. 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.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy adults and tests how the study medicine is absorbed, it's possible that you may need to pause some medications. Please check with the study team for specific guidance.

Is there any evidence suggesting that PF-08049820 is likely to be safe for humans?

Research has shown that PF-08049820 underwent testing to assess its safety in healthy adults. In these studies, participants generally tolerated the treatment well, with most experiencing no issues. No serious side effects were reported, suggesting it is relatively safe. However, like any medicine, some individuals might experience mild side effects.

The current study is in its early stages, focusing on understanding how the medicine works in the body, beyond just its safety. Early-stage trials ensure a treatment does not cause significant harm before testing it on larger groups.

Rabeprazole, used in this trial, has FDA approval for reducing stomach acid and is generally considered safe when taken as directed.

Prospective participants should consider these findings, which suggest the treatment is expected to be safe, but discussing potential risks with the study team remains important.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-08049820 because it introduces three different formulations that can be administered under various conditions, such as fasted or fed states, which is not typical for most existing treatments. This flexibility could lead to more tailored and effective dosing. Additionally, the study explores the impact of combining PF-08049820 with rabeprazole, which might enhance its effectiveness or reduce side effects, offering a novel approach compared to standard treatments. These aspects could potentially improve patient outcomes by providing more personalized treatment options.

What evidence suggests that PF-08049820 could be effective in healthy adults?

Research has shown that PF-08049820 is under investigation as a potential treatment for moderate to severe atopic dermatitis, a skin condition causing red, itchy patches. Earlier studies found that this medicine absorbs well into the bloodstream in healthy adults. This trial tests various formulations of PF-08049820 for safety and absorption under different conditions, crucial steps before proving its effectiveness for eczema. Early trials suggested it could be helpful, but further research is needed to confirm its benefits for skin conditions.14567

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 18 or older, with a body mass index between 16 and 32, and weighing more than 110 pounds. Participants should not have any significant health problems.

Inclusion Criteria

Body mass index (BMI) of 16-32 kg/m2 and a total body weight greater than 50kg (110 lb)
I am 18 years old or older.
I am a healthy male or female.

Exclusion Criteria

Evidence or history of clinically significant medical conditions
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening
Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants take three forms of study medicine, one after the other, with or without food for a total of five doses. Each dose is separated by a few days.

2 weeks
In-clinic stay

Follow-up Part A

Participants receive a telephone follow-up call about a month after the last dose.

4 weeks
1 visit (telephone)

Treatment Part B (Optional)

Participants take three forms of study medicine with or without food, and with or without rabeprazole, for a total of six doses. Each dose is separated by a few days.

3 weeks
In-clinic stay

Follow-up Part B (Optional)

Participants receive a follow-up phone call about a month after the last dose.

4 weeks
1 visit (telephone)

What Are the Treatments Tested in This Trial?

Interventions

  • PF-08049820
  • Rabeprazole

Trial Overview

The study tests how different forms of the medicine PF-08049820 are absorbed in the body when taken with or without food, and also when combined with rabeprazole (a stomach acid reducer). The study has two parts involving several doses over a few weeks.

How Is the Trial Designed?

7

Treatment groups

Experimental Treatment

Group I: Sequence 7 (Optional Part B)Experimental Treatment2 Interventions
Group II: Sequence 6 (Part A)Experimental Treatment1 Intervention
Group III: Sequence 5 (Part A)Experimental Treatment1 Intervention
Group IV: Sequence 4 (Part A)Experimental Treatment1 Intervention
Group V: Sequence 3 (Part A)Experimental Treatment1 Intervention
Group VI: Sequence 2 (Part A)Experimental Treatment1 Intervention
Group VII: Sequence 1 (Part A)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

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