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

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Plaque Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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:

Inclusion Criteria:

- 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:

- 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

NCT03210961
Pfizer
Recruiting
A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis

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A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis
A Phase 1, Within Cohort, Randomized, Double Blind, Third-party Open, Placebo-controlled, Single- And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06826647 In Healthy Subjects And Subjects With Plaque Psoriasis
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
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

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Double blind treatment

Primary Purpose: Treatment

Plaque Psoriasis
  • Drug: PF-06826647 tablet
    PF-06826647 tablet for oral administration
  • Drug: PF-06826647 oral suspension
    PF-06826647 suspension for oral administration (oral suspension to be administered to the 3mg starting dose cohort only)
  • Other: Placebo oral solution/suspension
    placebo oral solution for the single ascending dose, first cohort only
  • Other: Placebo tablet
    Matching placebo tablet
  • Experimental: PF-06826647 tablet
    Intervention: Drug: PF-06826647 tablet
  • Placebo Comparator: Placebo tablet
    Intervention: Other: Placebo tablet
  • Experimental: PF-06826647 oral suspension
    Intervention: Drug: PF-06826647 oral suspension
  • Placebo Comparator: Placebo oral solution/suspension
    Intervention: Other: Placebo oral solution/suspension
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
114
August 25, 2018
August 25, 2018   (Final data collection date for primary outcome measure)

Healthy Participants:

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)

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 28days 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:

Inclusion

  • 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 6months 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
  • 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 28days after the last dose of investigational product
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes

Contact: Peter Pfizer CT.gov Call Center, Winkle 1-800-718-1021 [email protected]
United States
 
 
NCT03210961
C2501001
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Principal Investigator: Peter Winkle, MD Anaheim Clinical Trials
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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