PF-08049820 for Drug Interaction Study

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Benzodiazepines, Dabigatran, Birth control

Disqualifiers: HIV, Hepatitis B/C, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 50

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how the new medicine, PF-08049820, interacts with other common medications, such as birth control pills, a sleep aid, and a blood clot preventer, when taken together. The goal is to understand how PF-08049820 alters the movement of these drugs through the body, which is crucial for planning future studies. Women who are generally healthy, have no serious medical issues, and weigh more than 110 pounds may be suitable candidates for this trial. Participants will stay in a clinic for about 25 days over a 12 to 13-week period. 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 treatment.

Do I need to stop my current medications to join the trial?

Yes, you may need to stop taking certain medications, as the trial excludes those who have used certain prescription or nonprescription drugs and supplements within 14 days or 5 half-lives before the first dose. It's best to discuss your current medications with the study team to see if they are allowed.

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

Research shows that PF-08049820 is under study to assess its safety in humans. Scientists have conducted studies to evaluate how well people tolerate this treatment. These studies have examined the effects of PF-08049820 in healthy adults to identify any potential side effects. So far, it appears generally well-tolerated, with most participants experiencing few negative reactions.

However, because the research remains in the early stages, complete safety information is not yet available. Scientists continue to explore how this treatment works in the body and what side effects it might cause. Current studies aim to understand these aspects to ensure its safety for future use in treating other conditions.

For those considering joining a trial for PF-08049820, it's important to know that safety is a top priority. Researchers will closely monitor participants for any unwanted effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PF-08049820 because it explores how this new compound interacts with other medications like midazolam, dabigatran etexilate, and oral contraceptives. Unlike current treatments that focus on single-drug efficacy, this study aims to understand the dynamics of drug-drug interactions, which is crucial for developing safer and more effective multi-drug regimens. This could lead to more personalized treatment plans, minimizing adverse effects when multiple medications are needed. Understanding these interactions also helps in tailoring dosages and optimizing therapeutic outcomes across various conditions.

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

Researchers are investigating how PF-08049820 interacts with other medications. In this trial, participants will join different treatment arms to assess these interactions. The main aim is to determine how PF-08049820 affects the action of drugs like birth control pills, midazolam, and dabigatran in the body. While direct evidence of its effectiveness as a treatment is not yet available, understanding these interactions is crucial. This information can guide future studies and ensure safety when using PF-08049820 with other medicines. Currently, the focus is on how PF-08049820 might influence other drugs, rather than treating a specific condition. ^{2 3 4 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Healthy adult women over 18, weighing more than 110 pounds with a BMI of 16 to 32 kg/m2 can join this study. They must be able to follow the study rules and have no serious medical issues or recent medication use that could affect results.

Inclusion Criteria

I am a woman over 18 and considered healthy by my doctor after several checks.

My BMI is between 16 and 32, and I weigh more than 110 lbs.

I am willing and able to follow the study's schedule and procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants receive a single dose of each medicine (midazolam, dabigatran, and birth control pills) to see how these medicines work alone

3 weeks

Overnight stay in the clinic for about 25 days

Drug-Drug Interaction (DDI)

Participants take PF-08049820 twice a day along with one of the other medicines to see how PF-08049820 changes the way those medicines move through the body

3 weeks

Overnight stay in the clinic for about 25 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PF-08049820

Trial Overview The trial is testing how PF-08049820 affects the body's processing of birth control pills, Midazolam (a relaxant/sleep aid), and Dabigatran (a blood clot preventer). Participants will first take each medicine alone, then combined with PF-08049820.

How Is the Trial Designed?

Group I: Drug Drug Interaction (DDI) midazolam Experimental Treatment 2 Interventions

Participants will receive a single dose of 2 mg midazolam in the morning on Days 2 and 10 only with PF-08049820 Days 1 to 10

Group II: DDI oral contraceptives Experimental Treatment 2 Interventions

Participants will receive a single dose of Portia (30 mcg of EE and 150 mcg of LN) or equivalent oral tablet in the morning on Day 1 only with PF-08049820 on Days 1 to 2

Group III: DDI dabigatran etexilate Experimental Treatment 2 Interventions

Participants will receive a single dose of 150 mg dabigatran etexilate in the morning on Day 1 only with PF-08049820 Days 1 to 2

Group IV: Baseline oral contraceptives Experimental Treatment 1 Intervention

Participants will receive a single dose of Portia (30 mcg of ethinyl estradiol (EE) and 150 mcg of levonorgestrel (LN)) or equivalent oral tablet in the morning on Day 1

Group V: Baseline dabigatran etexilate Experimental Treatment 1 Intervention

Participants will receive a single dose of 150 mg dabigatran etexilate in the morning on Day 1

Group VI: Baseline Midazolam Experimental Treatment 1 Intervention

Participants will receive a single dose of 2 mg midazolam in the morning on Day 1

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

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07172321

NCT07172321 | A Study to Learn How Different Forms of ... A Study to Learn How Different Forms of the Study Medicine Called PF 08049820 Are Taken up Into the Bloodstream in Healthy Adults.

2. withpower.com withpower.com/trial/phase-1-dermatitis-atopic-9-2025-b3684

PF-08049820 for Drug Interaction Study The purpose of this study is to see how a medicine called PF-08049820 affects how other medicines move through the body. This information will help plan ...

3. tipranks.com tipranks.com/news/company-announcements/pfizers-new-study-on-drug-interactions-what-investors-need-to-know-2

Pfizer's New Study on Drug Interactions: What Investors ... The study aims to understand how PF-08049820 affects the movement of other medications through the body, which is crucial for planning future ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06686797

NCT06686797 | A Study to Learn How Different Amounts of ... The purpose of this study is to learn about the safety of the study medicine called PF-08049820 in healthy adults.

5. cdn.pfizer.com cdn.pfizer.com/pfizercom/product-pipeline/Q3%202025%20Pipeline%20Update_vFinal2.pdf?VersionId=P0rxbPkdVnYPsxzIj_uO3wzb.sXa287Z

Pfizer Pipeline At the first interim efficacy analysis, the trial demonstrated a clinically meaningful and statistically significant improvement in event-free ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07216027

NCT07216027 | A Study to Learn About Study Medicine ... The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as ...

7. pfizerclinicaltrials.com pfizerclinicaltrials.com/find-a-trial/nct06686797-healthy-trial

Clinical Trial Seeking Healthy Volunteers | Pfizer The purpose of this study is to learn about the safety of the study medicine called PF-08049820 in healthy adults.