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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy Subjects

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
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

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

2. Body mass index of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)

3. Subjects who are willing and able to comply with all study procedures (including being
able to swallow up to 8 tablets/dose or 16 tablets/day)

4. For optional Japanese subjects only: Japanese subjects currently residing in the
United States who have 4 biologic Japanese grandparents born in Japan

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, neurologic, or
allergic disease

2. Subjects with history of sleep apnea

3. Any condition possibly affecting drug absorption (eg, gastrectomy)

4. Positive urine drug test

5. History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for males

6. Treatment with an investigational drug within 30 days or 5 half-lives of the first
dose of PF-06372865 (whichever is longer)

7. Clinically significant orthostatic hypotension at screening or screening supine BP
>=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of
supine rest

8. Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval >450 msec or
a QRS interval >120 msec

9. Subjects with any of the following abnormalities in clinical laboratory tests at
screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level
>=1.5x upper limit of normal (ULN); total bilirubin level >=1.5x ULN; subjects 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

10. Fertile male subjects who are unwilling or unable to use a highly effective method of
contraception for the duration of the study and for at least 60 days after the last
dose of PF-06372865

11. Male subjects whose partners are currently pregnant

12. Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half-lives (whichever is longer) prior to the first dose of PF-06372865

13. Use of herbal supplements or hormone replacement therapy within 28 days prior to the
first dose of PF-06372865

14. Blood donation of approximately 1 pint (500 mL) or more within 60 days prior to dosing

15. History of sensitivity to heparin or heparin-induced thrombocytopenia

16. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
testing for HIV, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis
C antibody

17. Other acute or chronic medical or psychiatric condition including recent or active
suicidal ideation or behavior or laboratory abnormality that may increase the risk
associated with study participation or PF-06372865 administration or may interfere
with the interpretation of study results

18. Subjects with active suicidal ideations or suicidal behavior within 5 years prior to
screening

19. Subjects with history of cyclic neutropenia.

20. Subjects with known history of hypersensitivity to benzodiazepines, or for whom
benzodiazepines would be contraindicated

21. Subjects who have previously been exposed to, or participated in a study with,
PF-06372865

22. Subjects with folate deficiency

23. Subjects who have had an X-ray within 4 weeks prior to screening

NCT03351751
Pfizer
Recruiting
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy Subjects

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[email protected]

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Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy Subjects
Official Title  ICMJE A PHASE 1, DOUBLE-BLIND (3RD PARTY OPEN), RANDOMIZED, PLACEBO-CONTROLLED, DOSE ESCALATION STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF REPEAT ORAL DOSES OF PF-06372865 IN HEALTHY ADULT SUBJECTS
Brief SummaryThe purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple repeat oral doses of PF-06372865 in healthy adult subjects.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Placebo
    Placebo
  • Drug: PF-06372865
    PF-06372865
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Subjects receiving placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06372865
    Subjects receiving PF-06372865
    Intervention: Drug: PF-06372865
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: February 20, 2018)
19
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2017)
40
Actual Study Completion Date  ICMJE February 28, 2018
Actual Primary Completion DateFebruary 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy female subjects of non-childbearing potential and/or male subjects between the ages of 18 and 55 years
  2. Body mass index of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
  3. Subjects who are willing and able to comply with all study procedures (including being able to swallow up to 8 tablets/dose or 16 tablets/day)
  4. For optional Japanese subjects only: Japanese subjects currently residing in the United States who have 4 biologic Japanese grandparents born in Japan

Exclusion Criteria:

  1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  2. Subjects with history of sleep apnea
  3. Any condition possibly affecting drug absorption (eg, gastrectomy)
  4. Positive urine drug test
  5. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males
  6. Treatment with an investigational drug within 30 days or 5 half-lives of the first dose of PF-06372865 (whichever is longer)
  7. Clinically significant orthostatic hypotension at screening or screening supine BP >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest
  8. Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec
  9. Subjects with any of the following abnormalities in clinical laboratory tests at screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >=1.5x upper limit of normal (ULN); total bilirubin level >=1.5x ULN; subjects 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 <=ULN
  10. Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 60 days after the last dose of PF-06372865
  11. Male subjects whose partners are currently pregnant
  12. Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of PF-06372865
  13. Use of herbal supplements or hormone replacement therapy within 28 days prior to the first dose of PF-06372865
  14. Blood donation of approximately 1 pint (500 mL) or more within 60 days prior to dosing
  15. History of sensitivity to heparin or heparin-induced thrombocytopenia
  16. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody
  17. Other acute or chronic medical or psychiatric condition including recent or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or PF-06372865 administration or may interfere with the interpretation of study results
  18. Subjects with active suicidal ideations or suicidal behavior within 5 years prior to screening
  19. Subjects with history of cyclic neutropenia.
  20. Subjects with known history of hypersensitivity to benzodiazepines, or for whom benzodiazepines would be contraindicated
  21. Subjects who have previously been exposed to, or participated in a study with, PF-06372865
  22. Subjects with folate deficiency
  23. Subjects who have had an X-ray within 4 weeks prior to screening
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03351751
Other Study ID Numbers  ICMJE B7431011
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
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 DateMay 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]

Call Now