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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: June 18, 2013
Last verified: June 2013

June 18, 2012
June 18, 2013
June 2012
August 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01626651 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Participants
An Open-Label, Sequential Design Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Subjects

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

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • 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.
Experimental: Ibrutinib and Ketoconazole
Interventions:
  • Drug: Ibrutinib
  • Drug: Ketoconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01626651
CR100870, PCI-32765CLL1002
Not Provided
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP