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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: March 20, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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: March 20, 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 May 22, 2013