Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers

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NCT02309827

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070, Belgium
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Contact
1-800-718-1021
[email protected]fizer.com
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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/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
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, 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.

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Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Study Arms  ICMJE
  • Experimental: Cohort 1: PF-06651600 or Placebo
    Single ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
    Intervention: Drug: PF-06651600 or Placebo
  • Experimental: Cohort 2: PF-06651600 or Placebo
    Single ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
    Intervention: Drug: PF-06651600 or Placebo
  • 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.
    Intervention: Drug: PF-06651600 or Placebo
  • 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.
    Intervention: Drug: PF-06651600 or Placebo
  • 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.
    Intervention: Drug: PF-06651600 or Placebo
  • 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.
    Intervention: Drug: PF-06651600 or Placebo
  • 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.
    Intervention: Drug: PF-06651600 or Placebo
  • 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.
    Intervention: Drug: PF-06651600 or Placebo
  • Experimental: Cohort 9: PF-06651600 or Placebo
    Multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
    Intervention: Drug: PF-06651600 or Placebo
Publications * Telliez JB, Dowty ME, Wang L, Jussif J, Lin T, Li L, Moy E, Balbo P, Li W, Zhao Y, Crouse K, Dickinson C, Symanowicz P, Hegen M, Banker ME, Vincent F, Unwalla R, Liang S, Gilbert AM, Brown MF, Hayward M, Montgomery J, Yang X, Bauman J, Trujillo JI, Casimiro-Garcia A, Vajdos FF, Leung L, Geoghegan KF, Quazi A, Xuan D, Jones L, Hett E, Wright K, Clark JD, Thorarensen A. Discovery of a JAK3-Selective Inhibitor: Functional Differentiation of JAK3-Selective Inhibition over pan-JAK or JAK1-Selective Inhibition. ACS Chem Biol. 2016 Dec 16;11(12):3442-3451. Epub 2016 Nov 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2016)		80
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2014)		56
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02309827
Other Study ID Numbers  ICMJE B7981001
2014-004326-17 ( EudraCT Number )
PF-06651600 ( Other Identifier: Alias Study Number )
JAK3 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP