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

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634345
• Other study ID #: B7451017
• Secondary ID: 2018-001943-29
• Status: Completed
• Phase: Phase 1
• Start date: September 12, 2018
• Est. completion date: December 13, 2018

Study information

• Verified date: January 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 13, 2018
• Est. primary completion date: December 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• Period 1 - Day 1: PF-04965842 administered
Period 1: Single administration of 100 mg PF 04965842.
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of subjects with Adverse events (AEs)	Number of subjects with Adverse events (AEs)	Screening up to 28 Days after the Last Dose of PF 04965842
Secondary	Number of subjects with laboratory tests findings of potential clinical importance	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
Secondary	Number of Subjects with clinically significant abnormal Vital Signs	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
Secondary	Number of Subjects with Electrocardiograms (ECGs) findings of potential clinical importance	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

External Links

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