A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06700841, With Bioavailability/Food Effect Investigation

Plaque Psoriasis Clinical Trial

Official title:

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-06700841 In Healthy Subjects And Subjects With Plaque Psoriasis And Bioavailability Of A Tablet Formulation Relative To Suspension Formulation And The Effect Of Food On A Tablet Formulation Of Pf-06700841

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310750
• Other study ID #: B7931001
• 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

• Plaque Psoriasis
• Psoriasis

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

External Links

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