CClinicalTrials.gg
Sign In
CompletedNCT07190430Updated Sep 9, 2026

A Study to Learn If the Study Medicine Called PF-08049820 Changes How the Body Processes the Other Study Medicines Called Oral Contraceptives, Midazolam, and Dabigatran in Healthy Adult Female Participants

A Phase 1 interventional study of PF-08049820 and Midazolam in Atopic Dermatitis, sponsored by Pfizer. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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 future studies. The other medicines include:

  • Birth control pills (containing ethinyl estradiol and levonorgestrel)
  • Midazolam (used to help people relax or sleep)
  • Dabigatran etexilate (used to prevent blood clots)

This study is seeking participants who:

  • are female and are 18 years or older
  • weigh more than 110 pounds (50 kg)
  • have a healthy body weight (not too low or too high)
  • are generally healthy with no serious medical problems. People with serious health problems, recent medicine use, or who had certain vaccines recently cannot join.
  • are willing to follow all the study rules The study has 6 parts, and each part happens one after the other. In the first 3 parts, participants take just one dose of each medicine (midazolam, dabigatran, and birth control pills) to see how these medicines work alone. In the last 3 parts, they 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. The whole study will take about 12 to13 weeks and participants will stay overnight in the clinic for about 25 days.
02

Conditions studied

  • Atopic Dermatitis

Browse trials for

Keywords

  • Healthy Volunteers
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 16 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Female participants ≥18 years of age, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • BMI of 16 to 32 kg/m2; and a total body weight >50 kg (110 lb).
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, Hepatitis B surface antigen (HBsAg), Antibody to hepatitis B surface antigen (HBsAb), Hepatitis B core antibody (HBcAb), or Hepatitis C Virus Antibody (HCVAb). A positive HBsAb result and a history of Hepatitis B vaccination is allowed.
  • History of thromboembolic diseases.
  • History of bleeding tendencies.
  • History of myocardial infarction, unstable angina, arterial revascularization, mechanical prosthetic heart valve, stroke, New York Association Functional Class II-IV heart failure, or transient ischemic attack.
  • Any known allergy or intolerance to midazolam or other drugs in the benzodiazepine class, and/or to dabigatran etexilate, and/or to OCs.
  • Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Use of certain prescription or nonprescription drugs and dietary (e.g. grapefruit) and herbal supplements within up to 14 days or 5 half-lives, whichever is longer, prior to the first dose of study intervention.
  • Recent exposure to live or attenuated vaccines within 28 days of the screening visit.
  • History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
  • Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Other
    Baseline Midazolam

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

    Drug: Midazolam

  • Other
    Baseline dabigatran etexilate

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

    Drug: Dabigatran Etexilate

  • Other
    Baseline oral contraceptives

    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

    Drug: Portia (EE and LN) or equivalent oral tablet

  • Experimental
    Drug Drug Interaction (DDI) midazolam

    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

    Drug: PF-08049820 · Drug: Midazolam

  • Experimental
    DDI dabigatran etexilate

    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

    Drug: PF-08049820 · Drug: Dabigatran Etexilate

  • Experimental
    DDI oral contraceptives

    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

    Drug: PF-08049820 · Drug: Portia (EE and LN) or equivalent oral tablet

Interventions

  • DrugPF-08049820

    Administered orally

  • DrugMidazolam

    Administered orally

  • DrugDabigatran Etexilate

    Administered orally

  • DrugPortia (EE and LN) or equivalent oral tablet

    Administered orally

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the curve (AUC) of Midazolam

    Time frame: From pre-dose up to 24 hours post dose in Periods 1 and 4

  2. PK: Plasma Maximum Concentration (Cmax) of Midazolam

    Time frame: From pre-dose up to 24 hours post dose in Periods 1 and 4

  3. PK: Area Under the curve (AUC) of dabigatran

    Time frame: From pre-dose up to 48 hours post dose in Periods 2 and 5

  4. PK: Cmax of dabigatran

    Time frame: From pre-dose up to 48 hours post dose in Periods 2 and 5

  5. PK: AUC of Ethinyl estradiol and levonorgestrel

    Time frame: From pre-dose up to 96 hours post dose in Periods 3 and 6

  6. PK: Cmax of Ethinyl estradiol and levonorgestrel

    Time frame: From pre-dose up to 96 hours post dose in Periods 3 and 6

Secondary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: First dose of study intervention until Follow Up Visit (28 to 35 days after the last dose)

  2. Number of Participants With Clinically Significant Change from Baseline in Laboratory Abnormalities

    Time frame: Baseline to Study Day 24

  3. Number of Participants With Clinically Significant Change from Baseline in Vital Signs

    Time frame: Baseline to Study Day 24

  4. Number of Participants With Clinically Significant Change from Baseline in 12-lead Electrocardiogram (ECG) Findings

    Time frame: Baseline to Study Day 24

07

Study locations

1 site
  • Pfizer Clinical Research Unit - New Haven
    New Haven, Connecticut 06511, United States
08

References and documents

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07190430
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 24, 2025
Start date
Oct 3, 2025
Primary completion
Dec 15, 2025
Completion
Dec 15, 2025
Last update
Sep 9, 2026

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dermatitis, Atopic→

Other studies from this sponsor

Pfizer

Start the discussion