Clinical trial NCT01626651: A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Participants
Official title: An Open-Label, Sequential Design Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Ketoconazole
Ibrutinib
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-06-25
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Ibrutinib plasma concentrations after administration on Day 1
timeFrame: over 72 hours after dosing on Day 1
measure: Ibrutinib plasma concentrations after administration on Day 7
timeFrame: over 72 hours after dosing on Day 7
measure: Metabolite PCI-45227 plasma concentrations after administration on Day 1
timeFrame: over 72 hours after dosing on Day 1
measure: Metabolite PCI-45227 plasma concentrations after administration on Day 7
timeFrame: over 72 hours after dosing on Day 7
Secondary outcomes:
measure: Ibrutinib urine concentrations after administration on Day 1
timeFrame: over 72 hours after dosing on Day 1
measure: Ibrutinib urine concentrations after administration on Day 7
timeFrame: over 72 hours after dosing on Day 7
measure: Metabolite PCI-45227 urine concentrations after administration on Day 1
timeFrame: over 72 hours after dosing on Day 1
measure: Metabolite PCI-45227 urine concentrations after administration on Day 7
timeFrame: over 72 hours after dosing on Day 7
measure: Incidence of adverse events as a measure of safety and tolerability
timeFrame: Approximately 41 days
Other outcomes:
Locations:
city: Neptune
country: United States
state: New Jersey
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: