A Study to Determine the Effect of Food on the Pharmacokinetics of PCI-32765

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

The purpose of this study is to compare the effect of food and two modified fasting regimens on the pharmacokinetics (study of what the body does to a drug) of PCI-32765 in healthy adult participants.

Key facts

Study ID

NCT01820936

Run by

Janssen Research & Development, LLC

People needed

52

Starts

2013-03-01

Expected to finish

2013-06-01

Last updated by the study team

2014-07-15

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Women must be postmenopausal or documented as surgically sterile
• Men must agree to use an adequate contraception method as deemed appropriate by the investigator during the study and for 3 months after receiving the last dose of study drug, and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
• Body mass index between 18 and 30 kg/m2and body weight not less than 50 kg
• Blood pressure (after sitting for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic

You may not qualify if…

• History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, history of immune disorders (eg, lupus, rheumatoid arthritis, psoriatic arthritis) or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• Clinically significant abnormal values for hematology, coagulation, PFA-100, clinical chemistry or urinalysis at screening
• Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) at screening
• Use of aspirin, non-steroidal anti-inflammatory agents, clopidogrel, Vitamin E supplements, fish oil, or flax seed within 1 week before PFA-100 assay test at screening
• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, and hormonal replacement therapy, within 14 days before the first dose of the study drug is scheduled
• Use of herbal supplements (such as St. John's Wort) within 30 days of the first dose administration
• Has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 2 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening and Day -1 of each treatment period
• History of clinically significant allergies, especially known hypersensitivity or intolerance to sulfonamide or beta-lactam antibiotics
• Known allergy to the study drug or any of the excipients of the formulation
• Known allergy to heparin or history of heparin induced thrombocytopenia
• Donated blood or blood products or had substantial loss of blood within 3 months before the first administration of study drug or intention to donate blood or blood products during the study
• Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half life, whichever is longer, before the first dose of the study drug is scheduled
• Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
• Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies
• History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or participant's verbal report and confirmed by cotinine test
• Preplanned surgery or procedures that would interfere with the conduct of the study

Where it is running

• Study site — Neptune City, New Jersey, United States

Full record on ClinicalTrials.gov

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