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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01626651
First received: June 18, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Ibrutinib
Drug: Ketoconazole
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Sequential Design Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Ibrutinib plasma concentrations after administration on Day 1 [ Time Frame: over 72 hours after dosing on Day 1 ] [ Designated as safety issue: No ]
  • Ibrutinib plasma concentrations after administration on Day 7 [ Time Frame: over 72 hours after dosing on Day 7 ] [ Designated as safety issue: No ]
  • Metabolite PCI-45227 plasma concentrations after administration on Day 1 [ Time Frame: over 72 hours after dosing on Day 1 ] [ Designated as safety issue: No ]
  • Metabolite PCI-45227 plasma concentrations after administration on Day 7 [ Time Frame: over 72 hours after dosing on Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ibrutinib urine concentrations after administration on Day 1 [ Time Frame: over 72 hours after dosing on Day 1 ] [ Designated as safety issue: No ]
  • Ibrutinib urine concentrations after administration on Day 7 [ Time Frame: over 72 hours after dosing on Day 7 ] [ Designated as safety issue: No ]
  • Metabolite PCI-45227 urine concentrations after administration on Day 1 [ Time Frame: over 72 hours after dosing on Day 1 ] [ Designated as safety issue: No ]
  • Metabolite PCI-45227 urine concentrations after administration on Day 7 [ Time Frame: over 72 hours after dosing on Day 7 ] [ Designated as safety issue: No ]
  • Incidence of adverse events as a measure of safety and tolerability [ Time Frame: Approximately 41 days ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibrutinib and Ketoconazole Drug: Ibrutinib
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.
Drug: Ketoconazole
Ketoconazole (400 mg [2 x 200 mg] once daily) will be orally administered on Days 4, 5, 6, 7, 8 and 9.

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626651

Locations
United States, New Jersey
Neptune, New Jersey, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01626651     History of Changes
Other Study ID Numbers: CR100870, PCI-32765CLL1002
Study First Received: June 18, 2012
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Healthy
Ketoconazole
Ibrutinib

Additional relevant MeSH terms:
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014