Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy Subjects
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Healthy female subjects of non-childbearing potential and/or male subjects between the ages of 18 and 55 years
- Body mass index of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)
- 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)
- For optional Japanese subjects only: Japanese subjects currently residing in the United States who have 4 biologic Japanese grandparents born in Japan
Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- Subjects with history of sleep apnea
- Any condition possibly affecting drug absorption (eg, gastrectomy)
- Positive urine drug test
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males
- Treatment with an investigational drug within 30 days or 5 half-lives of the first dose of PF-06372865 (whichever is longer)
- 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
- Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval \>450 msec or a QRS interval \>120 msec
- 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
- 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
- Male subjects whose partners are currently pregnant
- 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
- Use of herbal supplements or hormone replacement therapy within 28 days prior to the first dose of PF-06372865
- Blood donation of approximately 1 pint (500 mL) or more within 60 days prior to dosing
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- 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
- 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
- Subjects with active suicidal ideations or suicidal behavior within 5 years prior to screening
- Subjects with history of cyclic neutropenia.
- Subjects with known history of hypersensitivity to benzodiazepines, or for whom benzodiazepines would be contraindicated
- Subjects who have previously been exposed to, or participated in a study with, PF-06372865
- Subjects with folate deficiency
- Subjects who have had an X-ray within 4 weeks prior to screening
Key Trial Info
Start Date :
November 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2018
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03351751
Start Date
November 8 2017
End Date
February 28 2018
Last Update
June 3 2019
Active Locations (1)
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1
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511