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Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers

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NCT02309827

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT02309827
Pfizer
Completed
Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers

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Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy
Drug: PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
  • 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
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.
 
Completed
80
April 2016
April 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02309827
B7981001
2014-004326-17 ( EudraCT Number )
PF-06651600 ( Other Identifier: Alias Study Number )
JAK3 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2016

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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