Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers

September 15, 2016 updated by: Pfizer

A Phase 1, 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-06651600 In Healthy Subjects

This study is a first in human study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test single and multiple doses of PF-06651600. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 in healthy volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1070
        • Pfizer Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.
  • BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Evidence of personally signed and dated informed consent document.
  • Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.
  • Subjects must avoid high intensity UV light exposure (eg, active sunbathing, tanning beds/booths or sunlamps) from the first dose of study drug and for the duration of the study.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
  • Screening blood pressure >140/90 mm Hg.
  • Screening laboratory abnormalities as defined by the protocol.
  • Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1: PF-06651600 or Placebo
Single ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Drug: PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Experimental: Cohort 2: PF-06651600 or Placebo
Single ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Drug: PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Experimental: Cohort 3: PF-06651600 or Placebo
Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Drug: PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Experimental: Cohort 4: PF-06651600 or Placebo
Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Drug: PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Experimental: Cohort 5: PF-06651600 or Placebo
Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Drug: PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Experimental: Cohort 6: PF-06651600 or Placebo
Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Drug: PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Experimental: Cohort 7: PF-06651600 or Placebo
Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Drug: PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Experimental: Cohort 8: PF-06651600 or Placebo
Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Drug: PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Experimental: Cohort 9: PF-06651600 or Placebo
Multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Drug: PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
24 hour creatinine clearance (Single Dose)
Time Frame: Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
24 hour urine creatinine clearance in healthy subjects participating in the single dose periods. For the single dose period, assessment occurs on Study Days 0 and 1.
Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
24 hour creatinine clearance (Multiple Dose)
Time Frame: Multiple dose period, Days 0 (baseline), 7 and 14.
24 hour urine creatinine clearance in healthy subjects participating in the multiple dose period. For the multiple ascending dose period assessments occur on Study Days 7 and 14.
Multiple dose period, Days 0 (baseline), 7 and 14.
Change from baseline in urine volume (Single Dose)
Time Frame: Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
For the single dose period, assessment occurs on Study Days 0 and 1.
Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
Change from baseline in urine electrolytes (Single Dose)
Time Frame: Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
For the single dose period, assessment occurs on Study Days 0 and 1.
Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
Change from baseline in urine osmolality (Single Dose)
Time Frame: Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
For the single dose period, assessment occurs on Study Days 0 and 1.
Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
Change from baseline of urine volume (Multiple Dose)
Time Frame: Multiple dose period, Days 0 (baseline), 7 and 14.
For the multiple ascending dose period assessments occur on Study Days 7 and 14.
Multiple dose period, Days 0 (baseline), 7 and 14.
Change from baseline of urine electrolytes (Multiple Dose)
Time Frame: Multiple dose period, Days 0 (baseline), 7 and 14.
For the multiple ascending dose period assessments occur on Study Days 7 and 14.
Multiple dose period, Days 0 (baseline), 7 and 14.
Change from baseline in urine osmolality (Multiple Dose)
Time Frame: Multiple dose period, Days 0 (baseline), 7 and 14.
For the multiple ascending dose period assessments occur on Study Days 7 and 14.
Multiple dose period, Days 0 (baseline), 7 and 14.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Single Dose)
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Maximum Observed Plasma Concentration (Cmax)
0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Maximum Observed Plasma Concentration (Cmax)
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Single Dose)
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Cmax)
0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Time to Reach Maximum Observed Plasma Concentration (Cmax)
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600 (Single Dose)
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06651600 (Single Dose)
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Dose Normalized Maximum Observed Plasma Concentration (Cmaxdn) for PF-06651600 (Single Dose)
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Dose Normalized Maximum Observed Plasma Concentration (Cmaxdn)
0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Dose Normalized Maximum Observed Plasma Concentration (Cmaxdn) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Dose Normalized Maximum Observed Plasma Concentration (Cmaxdn)
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinfdn) for PF-06651600 (Single Dose)
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinfdn)
0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastdn) for PF-06651600 (Single Dose)
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastdn)
0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06651600 (Single Dose)
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Plasma Decay Half-Life (t1/2)
0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Plasma Decay Half-Life (t1/2)
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Mean Resonance Time (MRT) for PF-06651600 (Single Dose)
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Mean Resonance Time (MRT)
0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Mean Resonance Time (MRT) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Mean Resonance Time (MRT)
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Apparent Volume of Distribution (Vz/F) for PF-06651600 (Single Dose)
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Apparent Total Body Clearance (CL/F) for PF-06651600 (Single Dose)
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent total body clearance (CL/F) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Apparent Total Body Clearance (CL/F) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent total body clearance (CL/F) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Minimum Observed Plasma Concentration (Cmin) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Minimum Observed Plasma Concentration (Cmin)
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Average Concentration for Dosing Interval (12 or 24 hours) (Cav) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Average Concentration for Dosing Interval (12 or 24 hours) (Cav)
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Area Under the Curve for Dosing Interval (12 or 24 hours) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Area Under the Curve for Dosing Interval (12 or 24 hours)
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Dose Normalized Area Under the Curve for Dosing Interval (12 or 24 hours) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Dose Normalized Area Under the Curve for Dosing Interval (12 or 24 hours)
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Peak to Trough Fluctuation (PTF) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Peak to Trough Fluctuation (PTF)
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Observed Accumulation Ratio (Rac) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Observed Accumulation Ratio (Rac)
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Observed Accumulation Ratio for Cmax (RacCmax) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Observed Accumulation Ratio for Cmax (RacCmax)
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Steady State Accumulation Ratio (Rss) for PF-06651600 (Multiple Dose)
Time Frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Steady State Accumulation Ratio (Rss)
Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Amount of PF-066561600 Excreted Unchanged (Multiple Dose)
Time Frame: Day 14 (12, 24 hours post dose)
Concentration in urine.
Day 14 (12, 24 hours post dose)
Change from baseline of BCL2 gene expression in whole blood (Single Dose)
Time Frame: Days -1 and 1 (0, 1, 2, 4, 8, 12 and 24 hours post dose)
Days -1 and 1 (0, 1, 2, 4, 8, 12 and 24 hours post dose)
Change from baseline of BCL2 gene expression in whole blood (Multiple Dose)
Time Frame: Days 1, 5, 10, 14 (0, 1, 2, 4, 8, 12 and 24 hours post dose), 16, and 28
Days 1, 5, 10, 14 (0, 1, 2, 4, 8, 12 and 24 hours post dose), 16, and 28
Change from baseline of IP-10 protein concentration in serum (Multiple Dose)
Time Frame: Days 0, 2, 7, 14 (0, and 16 hours post dose) and 16
Days 0, 2, 7, 14 (0, and 16 hours post dose) and 16
Change from baseline of hsCRP protein concentration in serum (Multiple Dose)
Time Frame: Days 0, 2, 7, 14 (0, and 16 hours post dose) and 16
Days 0, 2, 7, 14 (0, and 16 hours post dose) and 16
Change from baseline of reticulocyte counts in whole blood (Single Dose)
Time Frame: Days 0, 2, 3, and 7
Days 0, 2, 3, and 7
Change from baseline of neutrophil counts in whole blood (Single Dose)
Time Frame: Days 0, 2, 3, and 7
Days 0, 2, 3, and 7
Change from baseline of hemoglobin level whole blood (Single Dose)
Time Frame: Days 0, 2, 3, and 7
Days 0, 2, 3, and 7
Change from baseline of reticulocyte counts in whole blood (Multiple Dose)
Time Frame: Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28
Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28
Change from baseline of neutrophil counts in whole blood (Multiple Dose)
Time Frame: Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28
Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28
Change from baseline of hemoglobin level in whole blood (Multiple Dose)
Time Frame: Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28
Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28
Renal Clearance (Multiple Dose)
Time Frame: Day 1, Day 14 (12, 24 hours post dose)
Day 1, Day 14 (12, 24 hours post dose)
Percentage of PF-066561600 Excreted Unchanged (Multiple Dose)
Time Frame: Day 14 (12, 24 hours post dose)
Concentration in urine.
Day 14 (12, 24 hours post dose)
Change from baseline of IP-10 gene expression in blood (Multiple Dose)
Time Frame: Days 0, 5, 10, 14 (0, 1, 2, 4, 8 and 12 hours post dose) and 16
Days 0, 5, 10, 14 (0, 1, 2, 4, 8 and 12 hours post dose) and 16
Change from baseline of IP-10 gene expression in blood (Single Dose)
Time Frame: Days 0, 1 (0, 1, 2, 4, 8 and 12 hours post dose) and 16
Days 0, 1 (0, 1, 2, 4, 8 and 12 hours post dose) and 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B7981001
  • 2014-004326-17 (EudraCT Number)
  • PF-06651600 (Other Identifier: Alias Study Number)
  • JAK3 (Other Identifier: Alias Study Number)

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