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Evaluation of Safety, Tolerability and Pharmacokinetics of Single Dose of PF-06480605 in Japanese Healthy Participants

Last updated on April 6, 2020

FOR MORE INFORMATION
Study Location
P-one Clinic
Hachioji-shi, Tokyo, 192-0071 Japan
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
20-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Male and female participants must be 20 to 55 years of age, inclusive, at the time of
signing the informed consent document (ICD).

2. Participants must have four Japanese grandparents born in Japan.

3. Male and female participants who are overtly healthy as determined by medical
evaluation including medical history, physical examination, cardiac tests and
laboratory tests.

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

5. Body mass index (BMI) of 17.5 to 25 kg/m2; and a total body weight >50 kg (110 lb).

6. Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the informed consent document (ICD) and in
this protocol.

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

1. 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).

2. History of human immunodeficiency virus (HIV) infection, hepatitis C or syphilis;
positive testing for HIV, hepatitis C antibody (HCVAb) or syphilis.

3. Infection with hepatitis B (HBV) according to the following algorithm using the
results of positive testing for hepatitis B surface antigen (HBsAg), hepatitis B core
antibody (HBcAb) and hepatitis B surface antibody (HBsAb) at screening.

1. If all three tests are negative, the participant is eligible for study inclusion.

2. If HBsAg is positive, the participant must be excluded from participation in the
study.

3. If HBsAg is negative, HBcAb is positive, and HBsAb is negative, the participant
must be excluded from participation in the study.

4. If HBsAg is negative, HBcAb is negative, HBsAb is positive, and prior HBV
vaccination is unequivocally documented, the participant is eligible for the
study and does not require hepatitis B DNA (HBVDNA) monitoring during the study.

5. If HBsAg is negative, HBcAb is negative, HBsAb is positive, and no unequivocal
documentation of prior HBV vaccination is available, the participant is required
to undergo HBVDNA reflex testing:

i. If HBVDNA is detected, the participant must be excluded from participation in the
study; ii. If HBVDNA is undetectable, the participant is eligible for study inclusion.
If the participant is included in the study, for subsequent visits HBVDNA testing must
be performed according to the Schedule of Activities.

f. If HBsAg is negative, HBcAb is positive, and HBsAb is positive, the participant is
required to undergo HBVDNA reflex testing: i. If HBVDNA is detected, the participant
must be excluded from participation in the study; ii. If HBVDNA is undetectable, the
participant is eligible for study inclusion. If the participant is included in the
study, for subsequent visits HBVDNA testing must be performed according to the
Schedule of Activities.

4. History of allergic or anaphylactic reaction to a therapeutic drug.

5. History of recent active infections within 28 days prior to the screening visit.

6. Participants with a fever within 48 hours prior to dosing.

7. History of tuberculosis or active, latent or inadequately treated tuberculosis
infection as defined by the following:

Have evidence of untreated or inadequately treated active or latent Mycobacterium
tuberculosis (TB) infection as evidenced by the following:

1. A positive QuantiFERON TB Gold In Tube (QFT-G) test or positive or borderline
T-SPOT.TB (T Spot) test performed within the 12 weeks prior to Day 1. If the
laboratory reports the test as indeterminate, the test should be repeated. If the
result of the repeat test is indeterminate, a purified protein derivative (PPD)
test may be substituted for the QFT-G test or T-Spot test only with approval from
the Pfizer Medical Monitor on a case by case basis.

2. Chest radiograph with changes suggestive of active TB infection within 3 months
prior to Screening. Chest radiograph should be performed according to local
standards of care or country specific guidelines.

3. History of either untreated or inadequately treated latent or active TB
infection.

If a participant has previously received an adequate course of therapy for either
latent (9 months of isoniazid in a locale where rates of primary multi drug resistant
TB infection are drug regimen) TB infection, neither a QFT-G test, a T-Spot test, nor a PPD test need
be obtained. Details of the previous course of therapy (eg, medication(s) used, dose,
duration of therapy) should be documented in the source documentation.

A chest radiograph should be obtained if not done within the 3 months prior to
Screening. To be considered eligible for the study, the chest radiograph must be
negative for active TB infection.

A participant who is currently being treated for active TB infection must be excluded
from the study.

A participant who is being treated for latent TB infection can only be enrolled with
confirmation of current incidence rates of multi drug resistant TB infection,
documentation of an adequate treatment regimen, and prior approval of the Sponsor.

8. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior 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 participant inappropriate for entry into
this study.

9. Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half lives (whichever is longer) prior to the first dose of
investigational product.

10. Recent exposure to live vaccines within 28 days of the screening visit.

11. Known exposure to anti-TL1A (PF-06480605) or any type of anti-TL1A therapy.

12. Previous administration with an investigational drug within 4 months (or as determined
by the local requirement) or 5 half lives preceding the first dose of investigational
product used in this study (whichever is longer).

13. A positive urine drug test.

14. Screening supine 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.

15. Baseline 12 lead electrocardiogram (ECG) that demonstrates clinically relevant
abnormalities that may affect participant safety or interpretation of study results
(eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block
[LBBB], signs of an acute or indeterminate age myocardial infarction, ST T interval
changes suggestive of myocardial ischemia, second or third degree atrioventricular
[AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline
uncorrected QT interval is >450 msec, this interval should be rate corrected using the
Fridericia method and the resulting QTcF should be used for decision making and
reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be
repeated 2 more times and the average of the 3 QTc or QRS values should be used to
determine the participant's eligibility. Computer interpreted ECGs should be overread
by a physician experienced in reading ECGs before excluding participants.

16. History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5
(male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule,
alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1
ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).

17. Blood donation (excluding plasma donations and platelet donations) of approximately
>=400 mL within 3 months or >=200 mL within a month prior to dosing. Additionally,
approximately >=400 mL within 4 months for female participants.

18. History of sensitivity to heparin or heparin induced thrombocytopenia.

19. History of substance abuse within 12 months of the screening visit.

20. Pregnant females; breastfeeding females.

21. Males 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 until discharge from the
study.

22. Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of this protocol.

23. Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Pfizer employees, including their family members, directly involved in the conduct of
the study.

NCT04269538
Pfizer
Recruiting
Evaluation of Safety, Tolerability and Pharmacokinetics of Single Dose of PF-06480605 in Japanese Healthy Participants

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Descriptive Information
Brief Title  ICMJE Evaluation of Safety, Tolerability and Pharmacokinetics of Single Dose of PF-06480605 in Japanese Healthy Participants
Official Title  ICMJE A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS FOLLOWING SINGLE SUBCUTANEOUS DOSE OF PF-06480605 IN JAPANESE HEALTHY PARTICIPANTS
Brief Summary This is a Phase 1, randomized, double-blind, third-party open (ie, participant-blind, investigator-blind and sponsor-open), placebo-controlled, dose escalating clinical study to evaluate the safety, tolerability, immunogenicity, PK and PD of PF-06480605 in Japanese healthy adult participants.
Detailed Description Approximately 16 participants are planned to be enrolled into the study. The study consists of 2 cohorts, and approximately 6 participants will be randomized to PF-06480605 and approximately 2 participants will be randomized to placebo in each cohort. Each participant will receive PF-06480605 or placebo subcutaneously.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06480605
    PF-06480605 150 mg and 450 mg SC dosing
    Other Name: Cohorts 1 and 2 Active
  • Drug: Placebo
    Placebo SC dosing
Study Arms  ICMJE
  • Experimental: SAD Cohorts 1-2 Experimental Arm
    Experimental Arm Active drug 150 mg and 450 mg SC dosing
    Intervention: Drug: PF-06480605
  • Placebo Comparator: SAD Cohorts 1-2 Placebo Arm
    Placebo Arm
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 12, 2020)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 8, 2020
Estimated Primary Completion Date April 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female participants must be 20 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
  2. Participants must have four Japanese grandparents born in Japan.
  3. Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, cardiac tests and laboratory tests.
  4. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  5. Body mass index (BMI) of 17.5 to 25 kg/m2; and a total body weight >50 kg (110 lb).
  6. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

Exclusion Criteria:

  1. 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).
  2. History of human immunodeficiency virus (HIV) infection, hepatitis C or syphilis; positive testing for HIV, hepatitis C antibody (HCVAb) or syphilis.
  3. Infection with hepatitis B (HBV) according to the following algorithm using the results of positive testing for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) and hepatitis B surface antibody (HBsAb) at screening.

    1. If all three tests are negative, the participant is eligible for study inclusion.
    2. If HBsAg is positive, the participant must be excluded from participation in the study.
    3. If HBsAg is negative, HBcAb is positive, and HBsAb is negative, the participant must be excluded from participation in the study.
    4. If HBsAg is negative, HBcAb is negative, HBsAb is positive, and prior HBV vaccination is unequivocally documented, the participant is eligible for the study and does not require hepatitis B DNA (HBVDNA) monitoring during the study.
    5. If HBsAg is negative, HBcAb is negative, HBsAb is positive, and no unequivocal documentation of prior HBV vaccination is available, the participant is required to undergo HBVDNA reflex testing:

    i. If HBVDNA is detected, the participant must be excluded from participation in the study; ii. If HBVDNA is undetectable, the participant is eligible for study inclusion. If the participant is included in the study, for subsequent visits HBVDNA testing must be performed according to the Schedule of Activities.

    f. If HBsAg is negative, HBcAb is positive, and HBsAb is positive, the participant is required to undergo HBVDNA reflex testing: i. If HBVDNA is detected, the participant must be excluded from participation in the study; ii. If HBVDNA is undetectable, the participant is eligible for study inclusion. If the participant is included in the study, for subsequent visits HBVDNA testing must be performed according to the Schedule of Activities.

  4. History of allergic or anaphylactic reaction to a therapeutic drug.
  5. History of recent active infections within 28 days prior to the screening visit.
  6. Participants with a fever within 48 hours prior to dosing.
  7. History of tuberculosis or active, latent or inadequately treated tuberculosis infection as defined by the following:

    Have evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection as evidenced by the following:

    1. A positive QuantiFERON TB Gold In Tube (QFT-G) test or positive or borderline T-SPOT.TB (T Spot) test performed within the 12 weeks prior to Day 1. If the laboratory reports the test as indeterminate, the test should be repeated. If the result of the repeat test is indeterminate, a purified protein derivative (PPD) test may be substituted for the QFT-G test or T-Spot test only with approval from the Pfizer Medical Monitor on a case by case basis.
    2. Chest radiograph with changes suggestive of active TB infection within 3 months prior to Screening. Chest radiograph should be performed according to local standards of care or country specific guidelines.
    3. History of either untreated or inadequately treated latent or active TB infection.

    If a participant has previously received an adequate course of therapy for either latent (9 months of isoniazid in a locale where rates of primary multi drug resistant TB infection are <5% or an acceptable alternative regimen) or active (acceptable multi drug regimen) TB infection, neither a QFT-G test, a T-Spot test, nor a PPD test need be obtained. Details of the previous course of therapy (eg, medication(s) used, dose, duration of therapy) should be documented in the source documentation.

    A chest radiograph should be obtained if not done within the 3 months prior to Screening. To be considered eligible for the study, the chest radiograph must be negative for active TB infection.

    A participant who is currently being treated for active TB infection must be excluded from the study.

    A participant who is being treated for latent TB infection can only be enrolled with confirmation of current incidence rates of multi drug resistant TB infection, documentation of an adequate treatment regimen, and prior approval of the Sponsor.

  8. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior 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 participant inappropriate for entry into this study.
  9. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product.
  10. Recent exposure to live vaccines within 28 days of the screening visit.
  11. Known exposure to anti-TL1A (PF-06480605) or any type of anti-TL1A therapy.
  12. Previous administration with an investigational drug within 4 months (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer).
  13. A positive urine drug test.
  14. Screening supine 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.
  15. Baseline 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
  16. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
  17. Blood donation (excluding plasma donations and platelet donations) of approximately >=400 mL within 3 months or >=200 mL within a month prior to dosing. Additionally, approximately >=400 mL within 4 months for female participants.
  18. History of sensitivity to heparin or heparin induced thrombocytopenia.
  19. History of substance abuse within 12 months of the screening visit.
  20. Pregnant females; breastfeeding females.
  21. Males 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 until discharge from the study.
  22. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
  23. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04269538
Other Study ID Numbers  ICMJE B7541006
Has Data Monitoring Committee No
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 Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2020

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]

Call Now