A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to assess the potential effects of ketoconazole on the pharmacokinetics of ibrutinib in healthy participants.

Key facts

Study ID

NCT01626651

Run by

Janssen Research & Development, LLC

People needed

21

Starts

2012-06-01

Expected to finish

2012-08-01

Last updated by the study team

2013-06-19

Who can join

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

You may qualify if…

• Body mass index (BMI) between 18 and 30 kg/m2, and body weight not less than 50 kg
• Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
• Non-smoker
• Must agree to use an adequate contraception method during the study and minimally 3 months after the last dose of ibrutinib, and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
• Signed an informed consent document

You may not qualify if…

• History of or current clinically significant medical illness
• Clinically significant abnormal physical examination, vital signs or electrocardiogram (ECG)
• Clinically significant abnormal values for laboratorial tests
• Use of any prescription or nonprescription medication, except for acetaminophen, within 3 days before the first dose of the study drug is schedule
• History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 2 years

Where it is running

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

Full record on ClinicalTrials.gov

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