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

Phase 1

Completed

• Conditions: Dermatitis, Atopic

• Registration Number: NCT03634345
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-16
• Study Start: 2018-09-12
• Primary Completion: 2018-12-13
• Study Completion: 2018-12-13
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Plasma Cmax for PF 04965842	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	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

Name	Time	Method
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 clinically significant abnormal Vital Signs
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	Number of Subjects with Electrocardiograms (ECGs) findings of potential clinical importance
Number of subjects with Adverse events (AEs)	Screening up to 28 Days after the Last Dose of PF 04965842	Number of subjects with Adverse events (AEs)
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 laboratory tests findings of potential clinical importance

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium