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

Last updated on October 9, 2018

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

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Safety and Pharmacokinetic Study of PF-06651600 in Japanese Healthy Volunteers
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
This 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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: PF-06651600
    PF-06651600 will be administered as tablet
  • Drug: Placebo
    Matching placebo will be administered as tablet
  • Experimental: PF-06651600
    Multiple ascending doses of PF-06651600
    Intervention: Drug: PF-06651600
  • Placebo Comparator: Placebo
    Multiple ascending doses of Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
November 22, 2017
October 27, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT03232905
B7981008
2017-001298-17 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 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 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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