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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT03351751

Run by

Pfizer

People needed

19

Starts

2017-11-08

Expected to finish

2018-02-28

Last updated by the study team

2019-06-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pfizer New Haven Clinical Research Unit — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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