Phase 1Phase 1NCT03647670

A Study to Determine the Effects of PF-04965842 on Midazolam PK in Healthy Volunteers

A Phase 1 study testing PF-04965842 and Midazolam in people with Phase 1, run by Pfizer at 1 site in Belgium.

Completed

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

Trial summary

This is a Phase 1, randomized, 2-way crossover, multiple dose, open label study of the effect of PF-04965842 on midazolam PK in healthy subjects. The study will demonstrate the effect of multiple dose PF-04965842 on the pharmacokinetics of a single, oral dose of midazolam in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Phase 1
What is being tested?: PF-04965842 and Midazolam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteBelgium
Study dates: 3 Jul 2018to 16 Oct 2018
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 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Healthy female subjects and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
Female subjects with child-bearing potential must not be intending to become pregnant, currently pregnant, or lactating. Conditions apply: negative pregnancy test, effective method of contraception
Non-childbearing potential must meet at least 1 of the following criteria: documented hysterectomy and/or bilateral oophorectomy, ovarian failure, achieved postmenopausal status confirmed with FSH
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, CV, hepatic, psych, neurological, or allergic disease (including drug allergies, but excluding seasonal)
Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination
Subjects, who according to the product label for midazolam, would be at increased risk if dosed with midazolam
Self-reported history or risk factors for QT prolongation or torsades de pointes, congenital deafness, family history of sudden death, and family history of long QT syndrome
Any condition possibly affecting drug absorption (eg, gastrectomy)
A positive urine drug test

Show all 26Show fewer

History of regular alcohol consumption exceeding 14 for female or 21 for male drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening
Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product (whichever is longer)
Following at least 5 minutes of supine rest, screening supine systolic BP <90 mm Hg or >=140 mm Hg, or screening supine diastolic BP <50 mm Hg or >=90 mm Hg. Any criteria met, BP should be repeated
Screening supine 12-lead ECG demonstrating: QTcF >450 msec or QRS interval >120 msec. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated
AST/SGOT or ALT/SGPT >=1.5 × ULN. Total bilirubin level >1× ULN; subjects with a hx of Gilbert's syndrome must have direct bilirubin <= ULN Known relevant history of elevated liver function tests (LFTs)
History of tuberculosis (TB) (active or latent) or inadequately treated TB infection. Positive QuantiFERON® - TB Gold test
Any history of chronic infections, any history of recurrent infections, any history of latent infections, or any acute infection within 2 weeks of baseline
History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster
History of sensitivity to heparin or heparin-induced thrombocytopenia
Pregnant or breastfeeding female; fertile male and WOCBP unwilling to use a highly effective method of contraception through study duration and for at least 28 days after the last dose
Use of medications and dietary supplements within 7 days or 5 half-lives prior to first dose, acetaminophen/paracetamol <=1 g/day exception. Herbal supplements and hormonal methods of contraception
Use of tobacco- or nicotine- containing products in excess of the equivalent of 5 cigarettes per day
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to first dose of investigational product
History of hypersensitivity to midazolam or any other bezodiazapine
History of HIV, hepatitis B or C; positive testing for HIV, HepBsAg, HepBcAb or HCVAb. As an exception, a positive HepBsAb as a result of subject vaccination is permissible
Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol
Investigator site staff members and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members
Other medical or psych condition including active suicidal ideation/ behavior or lab abnormality that the investigator deems inappropriate for this study or may interfere with study results
Have any malignancies or have a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ
Subjects at significant risk of suicidal or violent behavior

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Clinical Research Unit
Brussels, B-1070

Other trials in Belgium

About this study

Official title: A PHASE 1, RANDOMIZED, 2-WAY CROSSOVER, MULTIPLE DOSE, OPEN LABEL STUDY OF THE EFFECT OF PF-04965842 ON MIDAZOLAM PHARMACOKINETICS IN HEALTHY VOLUNTEERS

Read the detailed description

Subjects will be randomized to 1 of 2 treatment sequences as described below. A total of 24 healthy male and/or female subjects will be enrolled in the study so that 12 subjects will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods in a single fixed sequence. Subjects will be screened within 28 days of the first dose of study medication. Subjects will report to the clinical research unit (CRU) the day prior to (or Day -1) Day 1 dosing in Period 1 for both treatment sequences. In Sequence 1 subjects will remain in the CRU for a total of 11 days and 10 nights (including Period 1 and Period 2). In Sequence 2, Period 1, subjects will remain in the CRU for 9 days and 8 nights. In Sequence 2, Period 2, subjects will remain in the CRU for 3 days and 2 nights. In Sequence 1, Period 1, subjects will be dosed with a single administration of midazolam 2 mg oral solution on Day 1. Midazolam PK will then be assessed over the next 24 hours (hr). Period 1 will be immediately followed by Period 2 with no washout, in which subjects will be dosed with 200 mg PF-04965842 orally once daily (QD) for 7 days. Midazolam 2 mg oral solution will be administered on the morning of Day 2 and Day 7 within 5 minutes after PF-04965842 dosing. Midazolam PK will be assessed for 24 hr following dosing.In Sequence 2, Period 1, subjects will be dosed with 200 mg PF-04965842 orally QD for 7 days. Midazolam 2 mg oral solution will be administered on the morning of Day 2 and Day 7 within 5 minutes after PF-04965842 dosing. Midazolam PK will be assessed for 24 hr following dosing. Subjects will then undergo a washout period of at least 7 days. In Period 2 subjects will be dosed with a single administration of midazolam 2 mg oral solution on Day 1. Midazolam PK will then be assessed over the next 24 hr.

Conditions: Phase 1
Being tested: PF-04965842, Midazolam
Keywords: PF-04965842

What participants receive

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

PF-04965842Drug
Also called JAK1 Inhibitor
orally bioavailable small molecule that selectively inhibits JAK1 by blocking the adenosine triphosphate (ATP) binding site.
MidazolamDrug
substrate which undergoes extensive metabolism by CYP3A4 and CYP3A5 and acts as a sensitive probe for evaluating drug interaction with respect to these isoenzymes

Study groups in NCT03647670
Study group	Role	What they receive
Sequence 1	Other	In Sequence 1, Period 1, subjects will be dosed with a single administration of midazolam 2 mg oral solution on Day 1. Midazolam PK will then be assessed over the next 24 hours (hr). Period 1 will be immediately followed by Period 2 with no washout, in which subjects will be dosed with 200 mg PF-04965842 orally once daily (QD) for 7 days. Midazolam 2 mg oral solution will be administered on the morning of Day 2 and Day 7 within 5 minutes after PF-04965842 dosing. Midazolam PK will be assessed for 24 hr following dosing. Receives: Drug: PF-04965842; Drug: Midazolam
Sequence 2	Other	In Sequence 2, Period 1, subjects will be dosed with 200 mg PF-04965842 orally QD for 7 days. Midazolam 2 mg oral solution will be administered on the morning of Day 2 and Day 7 within 5 minutes after PF-04965842 dosing. Midazolam PK will be assessed for 24 hr following dosing. Subjects will then undergo a washout period of at least 7 days. In Period 2 subjects will be dosed with a single administration of midazolam 2 mg oral solution on Day 1. Midazolam PK will then be assessed over the next 24 hr. Receives: Drug: PF-04965842; Drug: Midazolam

What is being measured

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

AUCinf of midazolam.
To demonstrate the effect of multiple dose PF-04965842 on the pharmacokinetics of a single, oral dose of midazolam in healthy subjects. The lack of an effect of PF-04965842 on midazolam PK will be concluded if the 90% confidence interval for the ratio of adjusted geometric mean for AUCinf falls wholly within (80%, 125%).
Measured: 8 days

Secondary outcomes (9)

AUClast of midazolam
Adjusted mean differences and 90% confidence intervals for the differences will be exponentiated to provide estimates of the ratio of adjusted geometric means and 90% confidence intervals for the ratios.
Measured: 8 days
Blood Pressure
Number of Subjects with Data of Potential Clinical Concern
Measured: 8 days
Cmax of midazolam.
Adjusted mean differences and 90% confidence intervals for the differences will be exponentiated to provide estimates of the ratio of adjusted geometric means and 90% confidence intervals for the ratios.
Measured: 8 days
Tmax of midazolam.
Adjusted mean differences and 90% confidence intervals for the differences will be exponentiated to provide estimates of the ratio of adjusted geometric means and 90% confidence intervals for the ratios.
Measured: 8 days
t1/2 of midazolam.
Adjusted mean differences and 90% confidence intervals for the differences will be exponentiated to provide estimates of the ratio of adjusted geometric means and 90% confidence intervals for the ratios.
Measured: 8 days
Pulse
Number of Subjects with Data of Potential Clinical Concern
Measured: 8 days
Temperature
Number of subjects with data of potential clinical concern
Measured: 8 days
Adverse Events
Number of Subjects With Treatment-Related Treatment Emergent Adverse Events (TEAEs)
Measured: 8 days
Laboratory tests
Number of Subjects with Laboratory Test Abnormailities
Measured: 8 days

Timeline

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

3 Jul 201816 Oct 2018

First posted27 Aug 2018
Study start3 Jul 2018
Primary completion16 Oct 2018
Study completion16 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Phase 1Studies 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: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Natural log transformed area under the curve from zero to infinity, area under the plasma concentration-time curve from 0 to the time of last measurement and max plasma concentration of midazolam will be analyzed using a mixed effect model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adj mean differences (Test-Reference) and corresponding 90% CIs will be obtained from the model. The adjusted mean differences and 90% CIs for the differences will be exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios. Midazolam alone will be the Reference treatment, while the midazolam co-administered with PF-04965842 will be the Test treatment. The lack of an effect of PF-04965842 on midazolam PK will be concluded if the 90% CI for the ratio of adjusted geometric mean for AUCinf falls wholly within acceptance region (80%, 125%).
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03647670
Sponsor's protocol ID: B7451022
Other IDs: 2018-001198-26, 2018
Status last verified: Mar 2020
First submitted: 12 Jul 2018
Last updated: 23 Mar 2020
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.

Publications

Wang X, Dowty ME, Tripathy S, Le VH, Huh Y, Curto M, Winton JA, O'Gorman MT, Chan G, Malhotra BK. Assessment of the Effects of Abrocitinib on the Pharmacokinetics of Probe Substrates of Cytochrome P450 1A2, 2B6 and 2C19 Enzymes and Hormonal Oral Contraceptives in Healthy Individuals. Eur J Drug Metab Pharmacokinet. 2024 May;49(3):367-381. doi: 10.1007/s13318-024-00893-5. Epub 2024 Mar 30.
PubMed 38554232

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

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Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, RANDOMIZED, 2-WAY CROSSOVER, MULTIPLE DOSE, OPEN LABEL STUDY OF THE EFFECT OF PF-04965842 ON MIDAZOLAM PHARMACOKINETICS IN HEALTHY VOLUNTEERS
ClinicalTrials.gov ID: NCT03647670
Acronym / sponsor ID: B7451022
Conditions: Phase 1
Keywords: PF-04965842
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 3 Jul 2018 (actual)
Primary completion: 16 Oct 2018 (actual)
Study completion: 16 Oct 2018 (actual)
First posted: 27 Aug 2018 (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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Natural log transformed area under the curve from zero to infinity, area under the plasma concentration-time curve from 0 to the time of last measurement and max plasma concentration of midazolam will be analyzed using a mixed effect model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adj mean differences (Test-Reference) and corresponding 90% CIs will be obtained from the model. The adjusted mean differences and 90% CIs for the differences will be exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios. Midazolam alone will be the Reference treatment, while the midazolam co-administered with PF-04965842 will be the Test treatment. The lack of an effect of PF-04965842 on midazolam PK will be concluded if the 90% CI for the ratio of adjusted geometric mean for AUCinf falls wholly within acceptance region (80%, 125%).

Arm	Type	Receives
Sequence 1	Other	Drug: PF-04965842, Drug: MidazolamIn Sequence 1, Period 1, subjects will be dosed with a single administration of midazolam 2 mg oral solution on Day 1. Midazolam PK will then be assessed over the next 24 hours (hr). Period 1 will be immediately followed by Period 2 with no washout, in which subjects will be dosed with 200 mg PF-04965842 orally once daily (QD) for 7 days. Midazolam 2 mg oral solution will be administered on the morning of Day 2 and Day 7 within 5 minutes after PF-04965842 dosing. Midazolam PK will be assessed for 24 hr following dosing.
Sequence 2	Other	Drug: PF-04965842, Drug: MidazolamIn Sequence 2, Period 1, subjects will be dosed with 200 mg PF-04965842 orally QD for 7 days. Midazolam 2 mg oral solution will be administered on the morning of Day 2 and Day 7 within 5 minutes after PF-04965842 dosing. Midazolam PK will be assessed for 24 hr following dosing. Subjects will then undergo a washout period of at least 7 days. In Period 2 subjects will be dosed with a single administration of midazolam 2 mg oral solution on Day 1. Midazolam PK will then be assessed over the next 24 hr.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Healthy female subjects and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
Female subjects with child-bearing potential must not be intending to become pregnant, currently pregnant, or lactating. Conditions apply: negative pregnancy test, effective method of contraception
Non-childbearing potential must meet at least 1 of the following criteria: documented hysterectomy and/or bilateral oophorectomy, ovarian failure, achieved postmenopausal status confirmed with FSH

Key exclusion criteria (26 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, CV, hepatic, psych, neurological, or allergic disease (including drug allergies, but excluding seasonal)
Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination
Subjects, who according to the product label for midazolam, would be at increased risk if dosed with midazolam
Self-reported history or risk factors for QT prolongation or torsades de pointes, congenital deafness, family history of sudden death, and family history of long QT syndrome
Any condition possibly affecting drug absorption (eg, gastrectomy)

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-04965842Also: JAK1 Inhibitororally bioavailable small molecule that selectively inhibits JAK1 by blocking the adenosine triphosphate (ATP) binding site.	Drug	Sequence 1, Sequence 2
Midazolamsubstrate which undergoes extensive metabolism by CYP3A4 and CYP3A5 and acts as a sensitive probe for evaluating drug interaction with respect to these isoenzymes	Drug	Sequence 1, Sequence 2

Primary outcome

AUCinf of midazolam.
Time frame: 8 days
To demonstrate the effect of multiple dose PF-04965842 on the pharmacokinetics of a single, oral dose of midazolam in healthy subjects. The lack of an effect of PF-04965842 on midazolam PK will be concluded if the 90% confidence interval for the ratio of adjusted geometric mean for AUCinf falls wholly within (80%, 125%).

9 secondary outcomes

AUClast of midazolam
Time frame: 8 days
Blood Pressure
Time frame: 8 days
Cmax of midazolam.
Time frame: 8 days
Tmax of midazolam.
Time frame: 8 days
t1/2 of midazolam.
Time frame: 8 days
Pulse
Time frame: 8 days
Temperature
Time frame: 8 days
Adverse Events
Time frame: 8 days
Laboratory tests
Time frame: 8 days

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 23 Mar 2020.
Derived from this study: PubMed 38554232Wang X, Dowty ME, Tripathy S, Le VH, Huh Y, Curto M, Winton JA, O'Gorman MT, Chan G, Malhotra BK. Assessment of the Effects of Abrocitinib on the Pharmacokinetics of Probe Substrates of Cytochrome P450 1A2, 2B6 and 2C19 Enzymes and Hormonal Oral Contraceptives in Healthy Individuals. Eur J Drug Metab Pharmacokinet. 2024 May;49(3):367-381. doi: 10.1007/s13318-024-00893-5. Epub 2024 Mar 30.
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.

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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-04965842 and Midazolam in people with Phase 1, run by Pfizer at 1 site in Belgium.

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 6 inclusion and 26 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 23 Mar 2020. 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 Belgium. 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?

AUCinf of midazolam. (time frame: 8 days). 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 NCT03647670, which also lists 1 linked publication.

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 23 Mar 2020.