PHARMACOKINETIC CHARACTERIZATION OF PF-06651600 IN CHINESE ADULT PARTICIPANTS

NCT04634565

Last updated date
Study Location
Peking University Third Hospital
Beijing, Beijing, 100191, China
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

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By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Participants
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Only females of non-childbearing potential

- Male and female Chinese participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, and 12 lead ECG.

- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

- Body mass index (BMI) of 19 to 27 kg/m2; and a total body weight >50 kg.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Participants are excluded from the study if any of the following criteria apply:


- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).


- Any condition possibly affecting drug absorption (eg. Gastrectomy, cholecystectomy).


- History of human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C, or
syphilis; positive testing for HIV, hepatitis B, hepatitis C, and serological reaction
of syphilis. Infection with hepatitis B or hepatitis C viruses according to protocol
specific testing algorithm.


- Evidence or history of clinically significant dermatological condition (eg, contact
dermatitis or psoriasis) or visible rash present during physical examination.


- Any history of chronic infections, any history of recurrent infections, any history of
latent infections, or any acute infection within 2 weeks of baseline.


- History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent
localized dermatomal herpes zoster.


- Previous administration of an investigational drug within 90 days or 5 half lives
preceding the first dose of investigational product used in this study (whichever is
longer).

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE PHARMACOKINETIC CHARACTERIZATION OF PF-06651600 IN CHINESE ADULT PARTICIPANTS
Official Title  ICMJE A SINGLE CENTER, OPEN LABEL, SINGLE ARM STUDY TO INVESTIGATE THE REPEATED DOSE (FOR 10 DAYS) PHARMACOKINETICS AFTER ORAL ADMINISTRATION OF 200 MG PF-06651600 IN CHINESE HEALTHY ADULT PARTICIPANTS
Brief Summary This is an open label, single arm study in healthy Chinese male and/or female adult participants. Approximately 9 participants total are planned to participate in this study to ensure that a total of 8 evaluable participants (with all primary PK parameters) can complete the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy Participants
Intervention  ICMJE Drug: PF-06651600
oral PF-06651600 tablet 200 mg once daily
Study Arms  ICMJE Experimental: PF-06651600
PF-06651600 200 milligrams(mg) once daily for 10 days
Intervention: Drug: PF-06651600
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: November 17, 2020)
9
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 19, 2020
Actual Primary Completion Date November 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Only females of non-childbearing potential
  • Male and female Chinese participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, and 12 lead ECG.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Body mass index (BMI) of 19 to 27 kg/m2; and a total body weight >50 kg.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg. Gastrectomy, cholecystectomy).
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C, or syphilis; positive testing for HIV, hepatitis B, hepatitis C, and serological reaction of syphilis. Infection with hepatitis B or hepatitis C viruses according to protocol specific testing algorithm.
  • Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
  • Any history of chronic infections, any history of recurrent infections, any history of latent infections, or any acute infection within 2 weeks of baseline.
  • History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
  • Previous administration of an investigational drug within 90 days or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04634565
Other Study ID Numbers  ICMJE B7981036
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
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 February 2021

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