Atopic DermatitisPhase 1NCT07190430

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 study testing PF-08049820, Midazolam and Dabigatran Etexilate in people with Atopic Dermatitis, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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)… Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Atopic Dermatitis
What is being tested?: PF-08049820, Midazolam and Dabigatran Etexilate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 3 Oct 2025to 15 Dec 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Fixed Sequence Study to Evaluate The Effect of Steady-State Dosing of PF-08049820 on the Single Dose Pharmacokinetics of Oral Contraceptives, Midazolam, and Dabigatran in Healthy Adult Female Participants

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.

Conditions: Atopic Dermatitis
Being tested: PF-08049820, Midazolam, Dabigatran Etexilate, Portia (EE and LN) or equivalent oral tablet
Keywords: Healthy Volunteers
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-08049820Drug
Administered orally
MidazolamDrug
Administered orally
Dabigatran EtexilateDrug
Administered orally
Portia (EE and LN) or equivalent oral tabletDrug
Administered orally

Study groups in NCT07190430
Study group	Role	What they receive
Baseline Midazolam	Other	Participants will receive a single dose of 2 mg midazolam in the morning on Day 1 Receives: Drug: Midazolam
Baseline dabigatran etexilate	Other	Participants will receive a single dose of 150 mg dabigatran etexilate in the morning on Day 1 Receives: Drug: Dabigatran Etexilate
Baseline oral contraceptives	Other	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 Receives: Drug: Portia (EE and LN) or equivalent oral tablet
Drug Drug Interaction (DDI) midazolam	Experimental	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 Receives: Drug: PF-08049820; Drug: Midazolam
DDI dabigatran etexilate	Experimental	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 Receives: Drug: PF-08049820; Drug: Dabigatran Etexilate
DDI oral contraceptives	Experimental	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 Receives: Drug: PF-08049820; Drug: Portia (EE and LN) or equivalent oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Area Under the curve (AUC) of Midazolam
Measured: From pre-dose up to 24 hours post dose in Periods 1 and 4
PK: Plasma Maximum Concentration (Cmax) of Midazolam
Measured: From pre-dose up to 24 hours post dose in Periods 1 and 4
PK: Area Under the curve (AUC) of dabigatran
Measured: From pre-dose up to 48 hours post dose in Periods 2 and 5
PK: Cmax of dabigatran
Measured: From pre-dose up to 48 hours post dose in Periods 2 and 5
PK: AUC of Ethinyl estradiol and levonorgestrel
Measured: From pre-dose up to 96 hours post dose in Periods 3 and 6
PK: Cmax of Ethinyl estradiol and levonorgestrel
Measured: From pre-dose up to 96 hours post dose in Periods 3 and 6

Secondary outcomes (4)

Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: First dose of study intervention until Follow Up Visit (28 to 35 days after the last dose)
Number of Participants With Clinically Significant Change from Baseline in Laboratory Abnormalities
Measured: Baseline to Study Day 24
Number of Participants With Clinically Significant Change from Baseline in Vital Signs
Measured: Baseline to Study Day 24
Number of Participants With Clinically Significant Change from Baseline in 12-lead Electrocardiogram (ECG) Findings
Measured: Baseline to Study Day 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 202515 Dec 2025

First posted24 Sep 2025
Study start3 Oct 2025
Primary completion15 Dec 2025
Study completion15 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07190430
Sponsor's protocol ID: C6231004
Status last verified: Dec 2025
First submitted: 2 Sep 2025
Last updated: 9 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Fixed Sequence Study to Evaluate The Effect of Steady-State Dosing of PF-08049820 on the Single Dose Pharmacokinetics of Oral Contraceptives, Midazolam, and Dabigatran in Healthy Adult Female Participants
ClinicalTrials.gov ID: NCT07190430
Acronym / sponsor ID: C6231004
Conditions: Atopic Dermatitis
Keywords: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 3 Oct 2025 (actual)
Primary completion: 15 Dec 2025 (actual)
Study completion: 15 Dec 2025 (actual)
First posted: 24 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Baseline Midazolam	Other	Drug: MidazolamParticipants will receive a single dose of 2 mg midazolam in the morning on Day 1
Baseline dabigatran etexilate	Other	Drug: Dabigatran EtexilateParticipants will receive a single dose of 150 mg dabigatran etexilate in the morning on Day 1
Baseline oral contraceptives	Other	Drug: Portia (EE and LN) or equivalent oral tabletParticipants 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 Drug Interaction (DDI) midazolam	Experimental	Drug: PF-08049820, Drug: MidazolamParticipants 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
DDI dabigatran etexilate	Experimental	Drug: PF-08049820, Drug: Dabigatran EtexilateParticipants will receive a single dose of 150 mg dabigatran etexilate in the morning on Day 1 only with PF-08049820 Days 1 to 2
DDI oral contraceptives	Experimental	Drug: PF-08049820, Drug: Portia (EE and LN) or equivalent oral tabletParticipants 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

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-08049820Administered orally	Drug	DDI dabigatran etexilate, DDI oral contraceptives, Drug Drug Interaction (DDI) midazolam
MidazolamAdministered orally	Drug	Baseline Midazolam, Drug Drug Interaction (DDI) midazolam
Dabigatran EtexilateAdministered orally	Drug	Baseline dabigatran etexilate, DDI dabigatran etexilate
Portia (EE and LN) or equivalent oral tabletAdministered orally	Drug	Baseline oral contraceptives, DDI oral contraceptives

Primary outcome

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
PK: Plasma Maximum Concentration (Cmax) of Midazolam
Time frame: From pre-dose up to 24 hours post dose in Periods 1 and 4
PK: Area Under the curve (AUC) of dabigatran
Time frame: From pre-dose up to 48 hours post dose in Periods 2 and 5
PK: Cmax of dabigatran
Time frame: From pre-dose up to 48 hours post dose in Periods 2 and 5
PK: AUC of Ethinyl estradiol and levonorgestrel
Time frame: From pre-dose up to 96 hours post dose in Periods 3 and 6
PK: Cmax of Ethinyl estradiol and levonorgestrel
Time frame: From pre-dose up to 96 hours post dose in Periods 3 and 6

4 secondary outcomes

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)
Number of Participants With Clinically Significant Change from Baseline in Laboratory Abnormalities
Time frame: Baseline to Study Day 24
Number of Participants With Clinically Significant Change from Baseline in Vital Signs
Time frame: Baseline to Study Day 24
Number of Participants With Clinically Significant Change from Baseline in 12-lead Electrocardiogram (ECG) Findings
Time frame: Baseline to Study Day 24

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: 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.

Related trials for Atopic Dermatitis

RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-08049820, Midazolam and Dabigatran Etexilate in people with Atopic Dermatitis, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07190430.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.