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

January 29, 2019 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1070
        • Pfizer Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PF-04965842
investigational drug
Drug: Period 1 - Day 1: PF-04965842 administered
Period 1: Single administration of 100 mg PF 04965842.
Other Names:
  • Single administration of PF-04965842 in Period 1.
Drug: Period 2: Cohort 1: Fluvoxamine & PF-04965842
Cohort 1: Period 2: Administration of fluvoxamine from Day 1 to Day 9 and PF-04965842 on Day 8.
Other Names:
  • 9-day administration of Fluvoxamine and single administration of PF-04965842 on day 8.
Drug: Period 2: Cohort 2: Fluconazole & PF-04965842
Cohort 2: Period 2: Administration of fluconazole from Day 1 to Day 7 and PF-04965842 on Day 5.
Other Names:
  • 7-day administration of fluconazole and single administration of PF-04965842 on day 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
First 72 hours post PF-04965842 administration in Period 1 and Period 2
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)
First 72 hours post PF-04965842 administration in Period 1 and Period 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
Time Frame: Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 12, 2018

Primary Completion (ACTUAL)

December 13, 2018

Study Completion (ACTUAL)

December 13, 2018

Study Registration Dates

First Submitted

August 10, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (ACTUAL)

August 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B7451017
  • 2018-001943-29 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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