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Trial record 27 of 154 for:    Dermatitis, Atopic, 8

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

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ClinicalTrials.gov Identifier: NCT03634345
Recruitment Status : Completed
First Posted : August 16, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Period 1 - Day 1: PF-04965842 administered Drug: Period 2: Cohort 1: Fluvoxamine & PF-04965842 Drug: Period 2: Cohort 2: Fluconazole & PF-04965842 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : September 12, 2018
Actual Primary Completion Date : December 13, 2018
Actual Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  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)


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634345


Locations
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Belgium
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03634345     History of Changes
Other Study ID Numbers: B7451017
2018-001943-29 ( EudraCT Number )
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Atopic dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluconazole
Fluvoxamine
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators