NCT03634345

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

September 12, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

August 10, 2018

Last Update Submit

January 29, 2019

Conditions

Dermatitis, Atopic

Keywords

Atopic dermatitis

Outcome Measures

Primary Outcomes (2)

  • Plasma Cmax for PF 04965842

    Maximum Observed Plasma Concentration (Cmax) for PF 04965842

    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)

    First 72 hours post PF-04965842 administration in Period 1 and Period 2

Secondary Outcomes (4)

  • Number of subjects with Adverse events (AEs)

    Screening up to 28 Days after the Last Dose of PF 04965842

  • Number of subjects with laboratory tests findings of potential clinical importance

    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

    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

    Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2

Study Arms (1)

PF-04965842

EXPERIMENTAL

investigational drug

Drug: Period 1 - Day 1: PF-04965842 administeredDrug: Period 2: Cohort 1: Fluvoxamine & PF-04965842Drug: Period 2: Cohort 2: Fluconazole & PF-04965842

Interventions

Period 1 - Day 1: PF-04965842 administeredDRUG

Period 1: Single administration of 100 mg PF 04965842.

Also known as: Single administration of PF-04965842 in Period 1.
PF-04965842
Period 2: Cohort 1: Fluvoxamine & PF-04965842DRUG

Cohort 1: Period 2: Administration of fluvoxamine from Day 1 to Day 9 and PF-04965842 on Day 8.

Also known as: 9-day administration of Fluvoxamine and single administration of PF-04965842 on day 8.
PF-04965842
Period 2: Cohort 2: Fluconazole & PF-04965842DRUG

Cohort 2: Period 2: Administration of fluconazole from Day 1 to Day 7 and PF-04965842 on Day 5.

Also known as: 7-day administration of fluconazole and single administration of PF-04965842 on day 5.
PF-04965842

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 35226304DERIVED

  • 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.

    PMID: 35061234DERIVED

Related Links

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 16, 2018

Study Start

September 12, 2018

Primary Completion

December 13, 2018

Study Completion

December 13, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

BE(1)