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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02310750
Other study ID # B7931001
Secondary ID
Status Completed
Phase Phase 1
First received November 18, 2014
Last updated March 2, 2016
Start date November 2014
Est. completion date February 2016

Study information

Verified date March 2016
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The main purpose of the study is to determine if PF-06700841 is safe and well tolerated when administered to humans. A secondary purpose is to assess what the body does to PF-06700841 and to assess what PF-06700841 does to the body when given as single and multiple doses. The pharmacokinetic properties of different forms of PF-06700841 may be studied (tablet and solution/suspension forms).


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date February 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

Key Inclusion Criteria for Healthy Subject Cohorts:

- Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive

- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Key Inclusion Criteria for Psoriasis Subject Cohorts:

- Male subjects and/or female subjects of non-childbearing potential with a diagnosis of plaque psoriasis who are between the ages of 18 and 65 years, inclusive

- Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose

Exclusion Criteria:

Key Exclusion Criteria for Healthy Subject Cohorts:

- 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)

- Males of childbearing potential 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

Key Exclusion Criteria for Psoriasis Subject Cohorts:

- Currently have non plaque forms of psoriasis, (eg, erythrodermic, guttate, or pustular psoriasis).

- Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium

- Males of childbearing potential 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Drug:
PF-06700841 oral solution/suspension
Oral solution or suspension of study drug PF-06700841 (once daily or twice daily during multiple dosing periods)
Other:
Placebo
Matching placebo given during the single ascending and multiple dose periods
Drug:
PF-06700841 tablet
PF-06700841 tablet formulation administered during the bioavailability / food effect investigation

Locations

Country Name City State
United States Anaheim Clinical Trials, LLC Anaheim California

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in 24 hour urine creatinine clearance 24 hour urine creatinine clearance in healthy subjects participating in the single and multiple dose periods. For the single dose period, assessment occurs on Study Days 0 and 1. For the multiple ascending dose period, assessment occurs on Study Days 0 and 10. 24 hour urine creatinine clearance in psoriasis subjects: assessment occurs on Study Days 0, 10, and 28. 0-24 hours, Day 0 and Day 1 (single dose period), Day 10 (multiple dose period), Days 0, 10, and 28 (psoriasis subjects) Yes
Secondary Single dose Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose No
Secondary Single dose Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose No
Secondary Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]of PF-06700841 Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose No
Secondary Single dose Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (last)]of PF-06700841 Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose No
Secondary Single dose Area Under the Curve From Time Zero to Last Quantifiable Concentration divided by the dose [AUC (last)(dn)]of PF-06700841 Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose No
Secondary Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time divided by the dose [AUC (0 - 8) (dn)]of PF-06700841 Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose No
Secondary Single dose Plasma Decay Half-Life (t1/2) of PF-06700841 Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose No
Secondary Single dose Apparent Volume of Distribution (Vz/F) of PF-06700841 Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose No
Secondary Single dose Apparent Oral Clearance (CL/F) of PF-06700841 Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose No
Secondary Single dose Mean Residence Time (MRT) of PF-06700841 Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose No
Secondary Single dose Maximum Observed Plasma Concentration divided by the dose (Cmax (dn)) of PF-06700841 Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose No
Secondary Multiple dose Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Day 10 hour 0, 0.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 and 96 No
Secondary Multiple dose Maximum Observed Plasma Concentration divided by the dose (Cmax(dn)) of PF-06700841 Day 10 hour 0, 0.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 and 96 No
Secondary Multiple dose Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 Day 10 hour 0, 0.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 and 96 No
Secondary Multiple dose Area Under the Curve from Time Zero to end of dosing interval (AUCtau) of PF-06700841 Day 10 hour 0, 0.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 and 96 No
Secondary Multiple dose Area Under the Curve from Time Zero to end of dosing interval divided by the dose (AUCtau (dn)) of PF-06700841 Day 10 hour 0, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours No
Secondary Multiple dose Plasma Decay Half-Life (t1/2) of PF-06700841 Day 10 hours 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours No
Secondary Multiple dose Mean Residence Time (MRT) of PF-06700841 Day 10 hour 0, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours No
Secondary Multiple dose peak to trough fluctuation during multiple dose administration of PF-0670084 Day 10 hour 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 No
Secondary Multiple dose Volume of Distribution at Steady State (Vss) of PF-06700841 Day 10 hour 0, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours No
Secondary Multiple dose Apparent Oral Clearance (CL/F) of PF-06700841 Day 10 hour 0, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours No
Secondary Multiple dose Amount of unchanged PF-06700841 excreted into urine from time 0 to 24 hrs (Atau) Day 10 hour 0-24 No
Secondary Multiple dose percentage of unchanged PF-06700841 excreted into urine from time 0 to 24 hrs Day 10 Hour 0-24 No
Secondary Change from baseline in IP-10 protein concentration in serum or plasma Multiple dose day 2, 5, 10, 11 and 28 No
Secondary Multiple Dose Change from baseline in reticulocyte count (%) Day 2, 5, 10, 11 and 28 No
Secondary Multiple dose Change from baseline in serum high sensitivity C reactive protein Day 2, 5, 10, 11 and 28 No
Secondary Single Dose Change from baseline in absolute neutrophil count Day 2, 5, 8 No
Secondary Single Dose Change from baseline in reticulocyte count (%) Day 2, 5, 8 No
Secondary Multiple Dose Change from baseline in absolute neutrophil count Day 2, 5, 10, 11 and 28 No
Secondary Multiple dose Maximum Observed Plasma Concentration (Cmax) of PF- 06700841 in psoriasis subjects Day 28, hours 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 No
Secondary Multiple dose Maximum Observed Plasma Concentration (Cmax (dn) of PF-06700841 divided by the dose in psoriasis subjects Day 28, hours 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 No
Secondary Multiple dose Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 in psoriasis subjects Day 28, hours 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 No
Secondary Multiple dose Area Under the Curve from Time Zero to end of dosing interval (AUCtau) of PF-06700841 in psoriasis subjects Day 28, hours 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 No
Secondary Multiple dose Area Under the Curve from Time Zero to end of dosing interval (AUCtau) of PF-06700841 divided by the dose in psoriasis subjects Day 28, hours 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 No
Secondary Multiple dose Plasma Decay Half-Life (t1/2) of PF-06700841 in psoriasis subjects Day 28, hours 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 No
Secondary Multiple dose Mean Residence Time (MRT) of PF-06700841 in psoriasis subjects Day 28, hours 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 No
Secondary Multiple dose peak to trough fluctuation during multiple dose administration of PF-06700841 in psoriasis subjects Day 28 hours 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 No
Secondary Multiple dose Volume of Distribution at Steady State (Vss) of PF- 06700841 in psoriasis subjects Day 28, hours 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 No
Secondary Multiple dose Apparent Oral Clearance (CL/F) of PF-06700841 in psoriasis subjects Day 28, hours 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 No
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