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

Primary Purpose

Dermatitis, Atopic

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Period 1 - Day 1: PF-04965842 administered

Period 2: Cohort 1: Fluvoxamine & PF-04965842

Period 2: Cohort 2: Fluconazole & PF-04965842

About this trial

This is an interventional basic science trial for Dermatitis, Atopic focused on measuring Atopic dermatitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Sites / Locations

Pfizer Clinical Research Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PF-04965842

Arm Description

investigational drug

Outcomes

Primary Outcome Measures

Plasma Cmax for PF 04965842

Maximum Observed Plasma Concentration (Cmax) for PF 04965842

AUCinf for PF-04965842

Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF 04965842 (AUCinf)

Secondary Outcome Measures

Number of subjects with Adverse events (AEs)

Number of subjects with laboratory tests findings of potential clinical importance

Number of Subjects with clinically significant abnormal Vital Signs

Number of Subjects with Electrocardiograms (ECGs) findings of potential clinical importance

Full Information

NCT ID

NCT03634345

First Posted

August 10, 2018

Last Updated

January 29, 2019

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03634345

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

September 12, 2018 (Actual)

Primary Completion Date

December 13, 2018 (Actual)

Study Completion Date

December 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

Keywords

Atopic dermatitis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-04965842

Arm Type

Experimental

Arm Description

investigational drug

Intervention Type

Drug

Intervention Name(s)

Period 1 - Day 1: PF-04965842 administered

Other Intervention Name(s)

Single administration of PF-04965842 in Period 1.

Intervention Description

Period 1: Single administration of 100 mg PF 04965842.

Intervention Type

Drug

Intervention Name(s)

Period 2: Cohort 1: Fluvoxamine & PF-04965842

Other Intervention Name(s)

9-day administration of Fluvoxamine and single administration of PF-04965842 on day 8.

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Period 2: Cohort 2: Fluconazole & PF-04965842

Other Intervention Name(s)

7-day administration of fluconazole and single administration of PF-04965842 on day 5.

Intervention Description

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

Primary Outcome Measure Information:

Title

Plasma Cmax for PF 04965842

Description

Maximum Observed Plasma Concentration (Cmax) for PF 04965842

Time Frame

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

Title

AUCinf for PF-04965842

Description

Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF 04965842 (AUCinf)

Time Frame

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

Secondary Outcome Measure Information:

Title

Number of subjects with Adverse events (AEs)

Description

Number of subjects with Adverse events (AEs)

Time Frame

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

Title

Number of subjects with laboratory tests findings of potential clinical importance

Description

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

Title

Number of Subjects with clinically significant abnormal Vital Signs

Description

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

Title

Number of Subjects with Electrocardiograms (ECGs) findings of potential clinical importance

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Clinical Research Unit

City

Brussels

ZIP/Postal Code

B-1070

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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.

Citations:

PubMed Identifier

35226304

Citation

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.

Results Reference

derived

PubMed Identifier

35061234

Citation

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. Erratum In: Clin Pharmacokinet. 2022 Apr;61(4):591.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7451017&StudyName=A+Phase+1%2C+Open-label%2C+Randomized%2C+Fixed-sequence%2C+Parallel-cohort+Study+To+Estimate+The+Effect+Of+Fluvoxamine+Or+Fluconazole%2C+On+The+Pharmacokinetics%2C+Safety+And+Tolerability+Of+A+Single+Dose+Of+Pf-04965842+In+Healthy+Subjects

Description

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

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