A Study To Observe Safety And Blood Concentrations Of PF-06649751 During And Following The Oral Administration Of Multiple Doses Of PF-06649751 In Healthy Adult Western and Japanese Volunteers

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NCT02066909

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Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
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Contact
1-800-718-1021
[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.
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- Healthy males and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

- Cohort 9 only: Japanese subjects must have four biologic Japanese grandparents who were born in Japan.

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, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).


- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Observe Safety And Blood Concentrations Of PF-06649751 During And Following The Oral Administration Of Multiple Doses Of PF-06649751 In Healthy Adult Western and Japanese Volunteers
Official Title  ICMJE A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo Controlled, Dose Escalation, Parallel Group Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of Pf-06649751 In Healthy Western And Japanese Subjects
Brief Summary This study is designed to evaluate the safety and plasma concentrations of PF-06649751 in healthy volunteers following one or two times daily oral dosing of PF-06649751 for 14 days (Cohorts 1 - 4), 21 days (Cohort 5), or 28 days (Cohorts 6 - 8). Cohort 9 will dose Japanese healthy volunteers in a manner identical to Cohort 4 and is intended to bridge the safety/tolerability and PK data from the Western and Japanese populations.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: 0.15 mg PF-06649751
    Oral dosing of 0.15 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.
  • Drug: 0.5 mg PF-06649751
    Oral dosing of 0.5 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.
  • Drug: 0.5 mg PF-06649751
    Oral dosing of tablets up to 0.5 mg PF-06649751 given once-daily for 14 days.
  • Drug: 1.5 mg PF-06649751
    Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days.
  • Drug: 1.5 mg PF-06649751 21 Days
    Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 21 days.
  • Drug: 3.0 mg PF-06649751
    Oral dosing of tablets up to 3.0 mg PF-06649751 given once-daily for 28 days.
  • Drug: 5.0 mg PF-06649751
    Oral dosing of tablets up to 5.0 mg PF-06649751 given once-daily for 28 days.
  • Drug: 8.0 mg PF-06649751
    Oral dosing of tablets up to 8.0 mg PF-06649751 given once-daily for 28 days.
  • Drug: 1.5 mg PF-06649751 in healthy Japanese subjects
    Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days given in healthy Japanese subjects.
Study Arms  ICMJE
  • Experimental: Cohort 1
    Dosing in healthy Western subjects.
    Intervention: Drug: 0.15 mg PF-06649751
  • Experimental: Cohort 2
    Dosing in healthy Western subjects.
    Intervention: Drug: 0.5 mg PF-06649751
  • Experimental: Cohort 3
    Dosing in healthy Western subjects.
    Intervention: Drug: 0.5 mg PF-06649751
  • Experimental: Cohort 4
    Dosing in healthy Western subjects.
    Intervention: Drug: 1.5 mg PF-06649751
  • Experimental: Cohort 5
    Dosing in healthy Western subjects.
    Intervention: Drug: 1.5 mg PF-06649751 21 Days
  • Experimental: Cohort 6
    Dosing in healthy Western subjects.
    Intervention: Drug: 3.0 mg PF-06649751
  • Experimental: Cohort 7
    Dosing in healthy Western subjects.
    Intervention: Drug: 5.0 mg PF-06649751
  • Experimental: Optional Cohort 8
    Dosing in healthy Western subjects. Cohort may not be conducted.
    Intervention: Drug: 8.0 mg PF-06649751
  • Experimental: Cohort 9
    Dosing in healthy Japanese subjects.
    Intervention: Drug: 1.5 mg PF-06649751 in healthy Japanese subjects
Publications * Not Provided

*   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: June 23, 2015)		77
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2014)		50
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Cohort 9 only: Japanese subjects must have four biologic Japanese grandparents who were born in Japan.

Exclusion Criteria:

  • 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 the time of dosing).
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02066909
Other Study ID Numbers  ICMJE B7601002
2014-003776-23 ( EudraCT 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 June 2015

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