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Trial record 1 of 1 for:    NCT03351751
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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03351751
Recruitment Status : Completed
First Posted : November 24, 2017
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 13, 2017
First Posted Date  ICMJE November 24, 2017
Last Update Posted Date June 3, 2019
Actual Study Start Date  ICMJE November 8, 2017
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline up to 28-35 days after last dose of study medication ]
    Treatment-related AEs are any untoward medical occurrences attributed to study drug in a participant who received study drug. A serious adverse events (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to study drug is assessed by the investigator. Participants with multiple occurrences of an AE within a category are counted once within the category.
  • Change From Baseline in Vital Signs [ Time Frame: 0, 1, 2, 4, 8, and 12 hours post-dose on Days 1 and 21; also 0 and 2 hours post-dose on Days 4, 8, 11, 14, and 17 ]
    Measurement of systolic and diastolic blood pressure and pulse rate
  • Change From Baseline in Electrocardiogram (ECG) Parameters [ Time Frame: 0, 1, 2, 4, 8, and 12 hours post-dose on Days 1 and 21; also 0 and 2 hours post-dose on Days 4, 8, 11, 14, and 17 ]
    Measurement of the following ECG parameters: QT interval, QTcF, PR interval, RR interval, QRS interval, and heart rate.
  • Number of Participants With Clinical Laboratory Abnormalities [ Time Frame: Baseline up to 7-10 days after last dose of study medication ]
    Lab tests include: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein, folate); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy); other (follicle stimulating hormone, urine drug screening, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus).
  • Maximum Observed Plasma Concentration (Cmax) for PF-06372865 on Day 1 [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose ]
    Maximum observed plasma concentration
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06372865 on Day 1 [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose ]
    Time to reach maximum observed plasma concentration
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-06372865 on Day 1 [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose ]
    Area under the concentration curve from time 0 to end of the dosing interval. The dosing interval is 12 hours.
  • Maximum Observed Plasma Concentration (Cmax) for PF-06372865 on Day 21 [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose ]
    Maximum observed plasma concentration
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06372865 on Day 21 [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose ]
    Time to reach maximum observed plasma concentration
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-06372865 on Day 21 [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose ]
    Area under the concentration curve from time 0 to end of the dosing interval. The dosing interval is 12 hours.
  • Plasma Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 21 ]
    Time for the plasma concentration to decrease by one half.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03351751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Summary The 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 Description Not 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 Date February 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 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
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/data_requests.
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 May 2019

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