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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo

Drug: PF-06372865

Study type

Interventional

Funder types

Industry

Identifiers

NCT03351751

B7431011

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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