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Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation

NCT ID: NCT04065633

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-18

Study Completion Date

2019-12-14

Brief Summary

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Part A

* To measure and compare the amount of study drug in the blood after a single 200 mg dose of study drug given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions
* To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the variant Phase 3 tablet formulation and the Phase 3 tablet formulation under fasting conditions
* To estimate the effect of food on the amount of study drug in the blood after a single 200 mg dose of the commercial formulation

Part B

• To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions

Parts A \& B

* To collect samples for genotyping (CYP2C19 and CYP2C9 - enzymes that metabolize \[break down\] certain medications)

o Genotyping is the collection of a small sample of blood that contains your genes
* To evaluate the safety and tolerability of the study drug after single 200 mg doses of the three different formulations given to healthy participants
* To measure the amount of study drug in the blood after single doses of the different formulations
* To collect exploratory samples for biobanking o Biobanking is the collection and storage of blood samples for possible future testing

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Detailed Description

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The purpose of this study in healthy participants is to estimate the bioavailability (BA) of the commercial formulation of PF-04965842 and a variant formulation with slower dissolution relative to the Phase 3 formulation, to demonstrate the bioequivalence (BE) of the commercial formulation relative to the Phase 3 formulation, and to estimate the effect of food on the BA of the commercial formulation. This study consists of 2 parts: Part A is to estimate the relative BA (rBA) of single 200 mg doses of the commercial tablet formulation of PF-04965842 and a variant formulation of slower dissolution rate compared to the Phase 3 tablet formulation. The effect of food on the BA of the commercial tablet formulation will also be evaluated. Part B is to establish BE between the Phase 3 and commercial formulations. The study will follow a staged approach as the sample size for BE cannot be determined with currently available information.

Therefore, it is proposed to assess the maximum observed concentration (Cmax) and area under the curve (AUC) ratios between the Phase 3 and commercial formulations as well as the within-participant variability of Cmax and AUC values determined in Part A. Based on the results from Part A, the sample size of Part B will be determined and the decision to proceed to Part B will be made.

Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a Phase 1 randomized, open label, single-dose, crossover study in healthy participants to estimate the rBA of the commercial formulation of PF-04965842 (Test formulation 1) and the variant formulation with slower dissolution (Test formulation 2) compared to the Phase 3 formulation (Reference formulation), to demonstrate the BE of the commercial formulation relative to the Phase 3 formulation, and to estimate the effect of food on the rBA of the commercial formulation after a single 200 mg oral dose.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Part A sequence 1

Group Type EXPERIMENTAL

P3-Fast

Intervention Type DRUG

200 mg (2 × 100 mg) PF-04965842 Phase 3 tablet formulation under fasted conditions

Comm-Fast

Intervention Type DRUG

200 mg PF-04965842 commercial tablet formulation under fasted conditions

Vari-Fast

Intervention Type DRUG

200 mg PF-04965842 variant tablet formulation with slower dissolution under fasted conditions

Comm-Fed

Intervention Type DRUG

200 mg PF-04965842 commercial tablet formulation under fed conditions

Part A sequence 2

Group Type EXPERIMENTAL

P3-Fast

Intervention Type DRUG

200 mg (2 × 100 mg) PF-04965842 Phase 3 tablet formulation under fasted conditions

Comm-Fast

Intervention Type DRUG

200 mg PF-04965842 commercial tablet formulation under fasted conditions

Vari-Fast

Intervention Type DRUG

200 mg PF-04965842 variant tablet formulation with slower dissolution under fasted conditions

Comm-Fed

Intervention Type DRUG

200 mg PF-04965842 commercial tablet formulation under fed conditions

Part B sequence 1

Group Type EXPERIMENTAL

P3-Fast

Intervention Type DRUG

200 mg (2 × 100 mg) PF-04965842 Phase 3 tablet formulation under fasted conditions

Comm-Fast

Intervention Type DRUG

200 mg PF-04965842 commercial tablet formulation under fasted conditions

Part B sequence 2

Group Type EXPERIMENTAL

P3-Fast

Intervention Type DRUG

200 mg (2 × 100 mg) PF-04965842 Phase 3 tablet formulation under fasted conditions

Comm-Fast

Intervention Type DRUG

200 mg PF-04965842 commercial tablet formulation under fasted conditions

Interventions

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P3-Fast

200 mg (2 × 100 mg) PF-04965842 Phase 3 tablet formulation under fasted conditions

Intervention Type DRUG

Comm-Fast

200 mg PF-04965842 commercial tablet formulation under fasted conditions

Intervention Type DRUG

Vari-Fast

200 mg PF-04965842 variant tablet formulation with slower dissolution under fasted conditions

Intervention Type DRUG

Comm-Fed

200 mg PF-04965842 commercial tablet formulation under fed conditions

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)

Exclusion Criteria

* Any condition possibly affecting drug absorption (eg, gastrectomy).

* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis
* Evidence or history of clinically significant dermatological condition (eg, atopic dermatitis or psoriasis) .History of tuberculosis (TB) (active or latent) or inadequately treated TB infection.
* History of chronic infections, history of recurrent infections, history of latent infections, .History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
* history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Sylvester Pawlak, APRN

Role: PRINCIPAL_INVESTIGATOR

Pfizer

Locations

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New Haven Clinical Research Unit

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B7451032

To obtain contact information for a study center near you, click here.

Other Identifiers

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B7451032

Identifier Type: -

Identifier Source: org_study_id

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