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

NCT01626651 | Completed Phase 1

• 2 other identifiers: CR100870PCI-32765CLL1002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy; Ketoconazole; Ibrutinib

Outcome Measures

Primary Outcomes (4)

• Ibrutinib plasma concentrations after administration on Day 1

  over 72 hours after dosing on Day 1

• Ibrutinib plasma concentrations after administration on Day 7

  over 72 hours after dosing on Day 7

• Metabolite PCI-45227 plasma concentrations after administration on Day 1

  over 72 hours after dosing on Day 1

• Metabolite PCI-45227 plasma concentrations after administration on Day 7

  over 72 hours after dosing on Day 7

Secondary Outcomes (5)

• Ibrutinib urine concentrations after administration on Day 1

  over 72 hours after dosing on Day 1

• Ibrutinib urine concentrations after administration on Day 7

  over 72 hours after dosing on Day 7

• Metabolite PCI-45227 urine concentrations after administration on Day 1

  over 72 hours after dosing on Day 1

• Metabolite PCI-45227 urine concentrations after administration on Day 7

  over 72 hours after dosing on Day 7

• Incidence of adverse events as a measure of safety and tolerability

  Approximately 41 days

Study Arms (1)

Ibrutinib and Ketoconazole

EXPERIMENTAL

Drug: Ibrutinib; Drug: Ketoconazole

Interventions

Ibrutinib DRUG

A single oral dose of 120 mg ibrutinib (3 x 40 mg capsules) on Day 1, and 40 mg (1x 40 mg capsule) ibrutinib on Day 7.

Ibrutinib and Ketoconazole

Ketoconazole DRUG

Ketoconazole (400 mg \[2 x 200 mg\] once daily) will be orally administered on Days 4, 5, 6, 7, 8 and 9.

Ibrutinib and Ketoconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Neptune City, New Jersey, United States

Location

MeSH Terms

Interventions

ibrutinib; Ketoconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 25, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (1)