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Study to Assess Pharmacokinetics, Safety and Tolerability of PF-04965842 in Chinese Healthy Participants

Last updated on October 9, 2019

FOR MORE INFORMATION
Study Location
Beijing Hospital
Beijing, , 100021 China
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
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Body mass index (BMI) of 19 to 26 kg/m2; and a total body weight >50 kg.

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

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

- Evidence or clinically significant hematological, renal, endocrine, pulmonary,
gastrointestinal, cardiovascular, hepatic (including alcoholic liver disease,
nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver
diseases), 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, or hepatitis C;
positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis C antibody
(HCVAb) and serological reaction of syphilis. As an exception, a positive hepatitis B
surface antibody (HBsAb) finding as a result of participant vaccination is
permissible.

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

- History of tuberculosis (TB) or active or latent or inadequately treated infection,
positive QuantiFERON- TB Gold test or positive chest radiographs for active
tuberculosis infection.

- 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.

- Have any malignancies or have a history of malignancies with the exception of
adequately treated or excised non-metastatic basal cell or squamous cell cancer of the
skin, or cervical carcinoma in situ.

- A positive urine drug test.

- Screening sitting blood pressure (BP) >=140 mm Hg (systolic) or >=90 mm Hg
(diastolic), following at least 5 minutes of supine rest. If BP is >=140 mm Hg
(systolic) or >=90 mm Hg (diastolic), the BP should be repeated 2 more times and the
average of the 3 BP values should be used to determine the participant's eligibility.

- Participants with ANY of the following abnormalities in clinical laboratory tests at
screening, as assessed by the study-specific laboratory and confirmed by a single
repeat test, if deemed necessary: Aspartate aminotransferase (AST) or alanine
aminotransferase (ALT) level >=1.5 × upper limit of normal (ULN); Total bilirubin
level >1 × ULN; participants with a history of Gilbert's syndrome may have direct
bilirubin measured and would be eligible for this study provided the direct bilirubin
level is

NCT04099563
Pfizer
Not yet recruiting
Study to Assess Pharmacokinetics, Safety and Tolerability of PF-04965842 in Chinese Healthy Participants

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Descriptive Information
Brief Title  ICMJE Study to Assess Pharmacokinetics, Safety and Tolerability of PF-04965842 in Chinese Healthy Participants
Official Title  ICMJE A PHASE 1, OPEN-LABEL, SINGLE-ARM, SINGLE DOSE AND MULTIPLE DOSES STUDY TO ASSESS PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-04965842 IN CHINESE HEALTHY PARTICIPANTS
Brief SummaryThe purpose of this study is to assess the pharmacokinetics, safety and tolerability of PF-04965842 after single dose and once-daily multiple-doses in Chinese healthy participants.
Detailed DescriptionThis is a Phase 1, open-label, single-arm, single- and multiple-dose study to assess the pharmacokinetics, safety and tolerability of PF-04965842 in Chinese healthy participants.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
open-label, single-arm, single- and multiple-dose study

Masking: None (Open Label)
Primary Purpose: Treatment

Condition  ICMJE HEALTHY
Intervention  ICMJE Drug: PF-04965842

For this study, the investigational product is PF-04965842 (provided as 100 mg tablet).

PF-04965842 100 mg tablets will be provided by Pfizer. Investigational product will be presented to the participants in individual dosing containers

Other Names:
  • Following an overnight fast for at least 10 hours, participants will receive PF-04965842 oral single dose of 200 mg (2 × 100 mg tablets) on Day 1, at approximately 08:00 am plus or
  • minus 2 hours in the morning, and repeated doses on Day 3 to 8. On Day 8, the dosing will be under fasted
  • condition at approximately 8:00 am plus or minus 2 hours in the morning.
Study Arms  ICMJE Experimental: PF-04965842
Following an overnight fast for at least 10 hours, participants will receive PF-04965842 oral single dose of 200 mg (2 × 100 mg tablets) on Day 1, at approximately 08:00 am plus or minus 2 hours in the morning. On Days 3 to 8, participants will receive PF-04965842 oral dose of 200 mg (2 × 100 mg tablets) QD in the morning at approximately similar clock hour as on Day 1. On Day 3 and Day 6-8, the dosing of PF-04965842 will be after collection of pre-dose blood samples (under fasted condition for at least 10 hours). On Day 8, the dosing will be under fasted condition at approximately 8:00 am plus or minus 2 hours in the morning.
Intervention: Drug: PF-04965842
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 28, 2019
Estimated Primary Completion DateDecember 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body mass index (BMI) of 19 to 26 kg/m2; and a total body weight >50 kg.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Exclusion Criteria:

  • Evidence or clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic (including alcoholic liver disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver diseases), 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, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) and serological reaction of syphilis. As an exception, a positive hepatitis B surface antibody (HBsAb) finding as a result of participant vaccination is permissible.
  • Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
  • History of tuberculosis (TB) or active or latent or inadequately treated infection, positive QuantiFERON- TB Gold test or positive chest radiographs for active tuberculosis infection.
  • 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.
  • Have any malignancies or have a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
  • A positive urine drug test.
  • Screening sitting blood pressure (BP) >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >=1.5 × upper limit of normal (ULN); Total bilirubin level >1 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <=1 × ULN.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04099563
Other Study ID Numbers  ICMJE B7451028
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: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/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2019

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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