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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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
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 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.

NCT02066909
Pfizer
Completed
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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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
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
April 2015
April 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02066909
B7601002
2014-003776-23 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2015

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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