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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Ketoconazole

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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