Dermatitis, AtopicPhase 1NCT03634345

Drug Drug Interaction Study Evaluating the Effect of Fluvoxamine or Fluconazole on PK and Safety of PF-04965842.

A Phase 1 study testing Period 1 - Day 1: PF-04965842 administered, Period 2: Cohort 1: Fluvoxamine & PF-04965842 and Period 2: Cohort 2: Fluconazole & PF-04965842 in people with Dermatitis, Atopic, 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.

Official record

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Trial summary

A Phase 1, Open Label, Parallel-Cohort, Randomized, Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between PF-04965842 and Fkuvoxamine (cohort 1) or Fluconazole (Cohort 2) 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: Dermatitis, Atopic
What is being tested?: Period 1 - Day 1: PF-04965842 administered, Period 2: Cohort 1: Fluvoxamine & PF-04965842 and Period 2: Cohort 2: Fluconazole & PF-04965842
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteBelgium
Study dates: 12 Sep 2018to 13 Dec 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

Healthy male or female subjects.
Body mass index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lb).

Who cannot join

Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
History of hypersensitivity to or intolerance of fluvoxamine and/or fluconazole.
Any condition possibly affecting drug absorption.
A positive urine drug test.
Screening supine systolic BP <90 mm Hg or 140 mm Hg following at least 5 minutes of supine rest OR Screening supine diastolic BP <50 mm Hg or 90 mm Hg following at least 5 minutes of supine rest.
Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception.

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, OPEN-LABEL, RANDOMIZED, FIXED-SEQUENCE, PARALLEL-COHORT STUDY TO ESTIMATE THE EFFECT OF FLUVOXAMINE OR FLUCONAZOLE, ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF A SINGLE DOSE OF PF-04965842 IN HEALTHY SUBJECTS

Read the detailed description

A phase 1 study to evaluate the effect of fluvoxamine (a strong CYP2C19 and moderate CYP3A inhibitor) or fluconazole (a strong CYP2C19, moderate CYP2C9 and CYP3A inhibitor) on the pharmacokinetics, safety and tolerability of PF-04965842 in healthy subjects.

This study will be a Phase 1, open label, randomized, fixed-sequence, parallel-cohort study drug-drug interaction study. The study includes 2 periods:

In Period 1: all subjects will receive one single oral dose of 100 mg PF 04965842 tablet. (Treatment A). PK will be evaluated in the first 72 hours post adminstration of PF 04965842.

In Period 2:

Cohort 1: subjects will receive fluvoxamine (immediate release tablet 50 mg) once daily for 9 consecutive days; on Day 8, subjects will receive a single oral dose of 100 mg PF 04965842 approximately 3 hours after fluvoxamine administration. (Treatment B). PK will be evaluated in the first 72 hours post administration of PF 04965842.
Cohort 2: subjects will receive fluconazole capsule(s) once daily for 7 consecutive days (400 mg on Day 1 and 200 mg on Day 2-7 in Period 2); on Day 5, subjects will receive a single oral dose of 100 mg PF 04965842 approximately 1 hour after fluconazole administration. (Treatment C). PK will be evaluated in the first 72 hours post administration of PF 04965842.

Conditions: Dermatitis, Atopic
Being tested: Period 1 - Day 1: PF-04965842 administered, Period 2: Cohort 1: Fluvoxamine & PF-04965842, Period 2: Cohort 2: Fluconazole & PF-04965842
Keywords: Atopic dermatitis
Medical subject headings: Dermatitis, Atopic

What participants receive

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

Period 1 - Day 1: PF-04965842 administeredDrug
Also called Single administration of PF-04965842 in Period 1.
Period 1: Single administration of 100 mg PF 04965842.
Period 2: Cohort 1: Fluvoxamine & PF-04965842Drug
Also called 9-day administration of Fluvoxamine and single administration of PF-04965842 on day 8.
Cohort 1: Period 2: Administration of fluvoxamine from Day 1 to Day 9 and PF-04965842 on Day 8.
Period 2: Cohort 2: Fluconazole & PF-04965842Drug
Also called 7-day administration of fluconazole and single administration of PF-04965842 on day 5.
Cohort 2: Period 2: Administration of fluconazole from Day 1 to Day 7 and PF-04965842 on Day 5.

Study groups in NCT03634345
Study group	Role	What they receive
PF-04965842	Experimental	investigational drug Receives: Drug: Period 1 - Day 1: PF-04965842 administered; Drug: Period 2: Cohort 1: Fluvoxamine & PF-04965842; Drug: Period 2: Cohort 2: Fluconazole & PF-04965842

What is being measured

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

Plasma Cmax for PF 04965842
Maximum Observed Plasma Concentration (Cmax) for PF 04965842
Measured: First 72 hours post PF-04965842 administration in Period 1 and Period 2
AUCinf for PF-04965842
Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF 04965842 (AUCinf)
Measured: First 72 hours post PF-04965842 administration in Period 1 and Period 2

Secondary outcomes (4)

Number of subjects with Adverse events (AEs)
Number of subjects with Adverse events (AEs)
Measured: Screening up to 28 Days after the Last Dose of PF 04965842
Number of subjects with laboratory tests findings of potential clinical importance
Number of subjects with laboratory tests findings of potential clinical importance
Measured: Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2
Number of Subjects with clinically significant abnormal Vital Signs
Number of Subjects with clinically significant abnormal Vital Signs
Measured: Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2
Number of Subjects with Electrocardiograms (ECGs) findings of potential clinical importance
Number of Subjects with Electrocardiograms (ECGs) findings of potential clinical importance
Measured: Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2

Timeline

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

12 Sep 201813 Dec 2018

First posted16 Aug 2018
Study start12 Sep 2018
Primary completion13 Dec 2018
Study completion13 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Dermatitis, AtopicStudies 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
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03634345
Sponsor's protocol ID: B7451017
Other IDs: 2018-001943-29, 2018
Status last verified: Jan 2019
First submitted: 10 Aug 2018
Last updated: 30 Jan 2019
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, Wouters A, Tatulych S, Connell CA, Le VH, Tripathy S, O'Gorman MT, Winton JA, Yin N, Valdez H, Malhotra BK. Assessment of the Effects of Inhibition or Induction of CYP2C19 and CYP2C9 Enzymes, or Inhibition of OAT3, on the Pharmacokinetics of Abrocitinib and Its Metabolites in Healthy Individuals. Eur J Drug Metab Pharmacokinet. 2022 May;47(3):419-429. doi: 10.1007/s13318-021-00745-6. Epub 2022 Feb 28.
PubMed 35226304
Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.
PubMed 35061234

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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All Dermatitis, Atopic trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, FIXED-SEQUENCE, PARALLEL-COHORT STUDY TO ESTIMATE THE EFFECT OF FLUVOXAMINE OR FLUCONAZOLE, ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF A SINGLE DOSE OF PF-04965842 IN HEALTHY SUBJECTS
ClinicalTrials.gov ID: NCT03634345
Acronym / sponsor ID: B7451017
Conditions: Dermatitis, Atopic
Keywords: Atopic dermatitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 12 Sep 2018 (actual)
Primary completion: 13 Dec 2018 (actual)
Study completion: 13 Dec 2018 (actual)
First posted: 16 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

This study will be a Phase 1, open label, randomized, fixed-sequence, parallel-cohort study drug-drug interaction study. The study includes 2 periods:

In Period 1: all subjects will receive one single oral dose of 100 mg PF 04965842 tablet. (Treatment A). PK will be evaluated in the first 72 hours post adminstration of PF 04965842.

In Period 2:

Cohort 1: subjects will receive fluvoxamine (immediate release tablet 50 mg) once daily for 9 consecutive days; on Day 8, subjects will receive a single oral dose of 100 mg PF 04965842 approximately 3 hours after fluvoxamine administration. (Treatment B). PK will be evaluated in the first 72 hours post administration of PF 04965842.
Cohort 2: subjects will receive fluconazole capsule(s) once daily for 7 consecutive days (400 mg on Day 1 and 200 mg on Day 2-7 in Period 2); on Day 5, subjects will receive a single oral dose of 100 mg PF 04965842 approximately 1 hour after fluconazole administration. (Treatment C). PK will be evaluated in the first 72 hours post administration of PF 04965842.

Study design

Primary purpose: Basic science
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PF-04965842	Experimental	Drug: Period 1 - Day 1: PF-04965842 administered, Drug: Period 2: Cohort 1: Fluvoxamine & PF-04965842, Drug: Period 2: Cohort 2: Fluconazole & PF-04965842investigational drug

Who may qualify

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

Key inclusion criteria (2 listed)

Healthy male or female subjects.
Body mass index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lb).

Key exclusion criteria (7 listed)

Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
History of hypersensitivity to or intolerance of fluvoxamine and/or fluconazole.
Any condition possibly affecting drug absorption.
A positive urine drug test.

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
Period 1 - Day 1: PF-04965842 administeredAlso: Single administration of PF-04965842 in Period 1.Period 1: Single administration of 100 mg PF 04965842.	Drug	PF-04965842
Period 2: Cohort 1: Fluvoxamine & PF-04965842Also: 9-day administration of Fluvoxamine and single administration of PF-04965842 on day 8.Cohort 1: Period 2: Administration of fluvoxamine from Day 1 to Day 9 and PF-04965842 on Day 8.	Drug	PF-04965842
Period 2: Cohort 2: Fluconazole & PF-04965842Also: 7-day administration of fluconazole and single administration of PF-04965842 on day 5.Cohort 2: Period 2: Administration of fluconazole from Day 1 to Day 7 and PF-04965842 on Day 5.	Drug	PF-04965842

Primary outcome

Plasma Cmax for PF 04965842
Time frame: First 72 hours post PF-04965842 administration in Period 1 and Period 2
Maximum Observed Plasma Concentration (Cmax) for PF 04965842
AUCinf for PF-04965842
Time frame: First 72 hours post PF-04965842 administration in Period 1 and Period 2
Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF 04965842 (AUCinf)

4 secondary outcomes

Number of subjects with Adverse events (AEs)
Time frame: Screening up to 28 Days after the Last Dose of PF 04965842
Number of subjects with laboratory tests findings of potential clinical importance
Time frame: Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2
Number of Subjects with clinically significant abnormal Vital Signs
Time frame: Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2
Number of Subjects with Electrocardiograms (ECGs) findings of potential clinical importance
Time frame: Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2

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 30 Jan 2019.
Derived from this study: PubMed 35226304Wang X, Dowty ME, Wouters A, Tatulych S, Connell CA, Le VH, Tripathy S, O'Gorman MT, Winton JA, Yin N, Valdez H, Malhotra BK. Assessment of the Effects of Inhibition or Induction of CYP2C19 and CYP2C9 Enzymes, or Inhibition of OAT3, on the Pharmacokinetics of Abrocitinib and Its Metabolites in Healthy Individuals. Eur J Drug Metab Pharmacokinet. 2022 May;47(3):419-429. doi: 10.1007/s13318-021-00745-6. Epub 2022 Feb 28.
Derived from this study: PubMed 35061234Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.
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 Dermatitis, Atopic

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
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Not yet recruitingPhase 1
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RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
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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?

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 2 inclusion and 7 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 30 Jan 2019. 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?

Plasma Cmax for PF 04965842 (time frame: First 72 hours post PF-04965842 administration in Period 1 and Period 2). The study lists 2 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 NCT03634345, which also lists 2 linked publications.

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 30 Jan 2019.