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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Ketoconazole

Drug: Ibrutinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01626651

CR100870

PCI-32765CLL1002 (Other Identifier)

Details and patient eligibility

About

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

Full description

This is a single-center, open-label (all people know the identity of the intervention), sequential design study in healthy men. All participants will receive ibrutinib on Day 1 and ibrutinib in combination with ketoconazole on Day 7. Food will be restricted from the evening before dosing until 4 hours after dosing on Days 1 and 7. Following an overnight fast, ketoconazole will be given on Days 4 to 6, 1 hour prior to ibrutinib dosing on Day 7, and again on Days 8 and 9. All ibrutinib and ketoconazole doses will be administered with water. The participants will leave the study center on Day 10.

Enrollment

21 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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