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Safety and Pharmacokinetic Study of PF-06651600 in Japanese Healthy Volunteers

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
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

- Subject must have four Japanese grandparents who were born in Japan.

- Healthy male subjects and/or female subjects of non-childbearing potential between the
ages of 18 and 55 years, inclusive

- No evidence of active or latent or inadequately treated infection with Mycobacterium
tuberculosis (TB)

- BMI of 17.5 to 27.5 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.

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.

- Males of childbearing potential who are unwilling or unable to use a highly effective
method of contraception as outlined in this protocol for the duration of the study and
for at least 28 days after the last dose of investigational product

- 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.

NCT03232905
Pfizer
Recruiting
Safety and Pharmacokinetic Study of PF-06651600 in Japanese Healthy Volunteers

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Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetic Study of PF-06651600 in Japanese Healthy Volunteers
Official Title  ICMJE A Phase 1, Randomized, Double-blind, Third-party Open, Placebo-controlled Study To Evaluate The Safety, Tolerability, And Pharmacokinetics After Multiple Oral Doses Of Pf-06651600 In Healthy Japanese Subjects
Brief SummaryThis study is a phase 1 study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 after multiple oral doses of PF-06651600 in Japanese healthy volunteers.
Detailed DescriptionNot 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: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06651600
    PF-06651600 will be administered as tablet
  • Drug: Placebo
    Matching placebo will be administered as tablet
Study Arms  ICMJE
  • Experimental: PF-06651600
    Multiple ascending doses of PF-06651600
    Intervention: Drug: PF-06651600
  • Placebo Comparator: Placebo
    Multiple ascending doses of Placebo
    Intervention: Drug: Placebo
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: December 4, 2017)
6
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2017)
8
Actual Study Completion Date  ICMJE November 22, 2017
Actual Primary Completion DateOctober 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must have four Japanese grandparents who were born in Japan.
  • Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
  • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
  • BMI of 17.5 to 27.5 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.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
  • 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 NCT03232905
Other Study ID Numbers  ICMJE B7981008
2017-001298-17 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2017

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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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