A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-14

Study Completion Date

2019-01-25

Brief Summary

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This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis.

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Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Combination single and multiple ascending dose design. Cohorts of participants are assigned to receive interventions based on acceptable safety, tolerability, and pharmacokinetics of previous dose cohort

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind treatment

Study Groups

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PF-06826647 tablet

Group Type EXPERIMENTAL

PF-06826647 tablet

Intervention Type DRUG

PF-06826647 tablet for oral administration

Placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type OTHER

Matching placebo tablet

PF-06826647 oral suspension

Group Type EXPERIMENTAL

PF-06826647 oral suspension

Intervention Type DRUG

PF-06826647 suspension for oral administration (oral suspension to be administered to the 3mg starting dose cohort only)

Placebo oral solution/suspension

Group Type PLACEBO_COMPARATOR

Placebo oral solution/suspension

Intervention Type OTHER

placebo oral solution for the single ascending dose, first cohort only

Interventions

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PF-06826647 tablet

PF-06826647 tablet for oral administration

Intervention Type DRUG

PF-06826647 oral suspension

PF-06826647 suspension for oral administration (oral suspension to be administered to the 3mg starting dose cohort only)

Intervention Type DRUG

Placebo oral solution/suspension

placebo oral solution for the single ascending dose, first cohort only

Intervention Type OTHER

Placebo tablet

Matching placebo tablet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects between ages of 18-55 years
* Healthy female subjects of non-childbearing potential between the ages of 18-55 years
* Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight \>50kg (110lbs).
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
* (Optional) Japanese subjects who have four Japanese biologic grandparents born in Japan

* Healthy male subjects between ages of 18-65 years
* Healthy female subjects of non-childbearing potential between the ages of 18-65 years
* Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose
* Have plaque-type psoriasis covering at least 15% of total body surface area (BSA) at Day-1(prior to randomization in the study
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
* Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential
* Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
* Have a clinically significant infection currently or within 6 months of first dose of study drug

Psoriasis Participants:

* Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis
* Have a clinically significant infection currently or within 6 months of first dose of study drug, or a history of chronic or recurrent infectious disease
* Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential
* Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes