This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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: 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 ]
  • Ibrutinib plasma concentrations after administration on Day 7 [ Time Frame: over 72 hours after dosing on Day 7 ]
  • Metabolite PCI-45227 plasma concentrations after administration on Day 1 [ Time Frame: over 72 hours after dosing on Day 1 ]
  • Metabolite PCI-45227 plasma concentrations after administration on Day 7 [ Time Frame: over 72 hours after dosing on Day 7 ]

Secondary Outcome Measures:
  • Ibrutinib urine concentrations after administration on Day 1 [ Time Frame: over 72 hours after dosing on Day 1 ]
  • Ibrutinib urine concentrations after administration on Day 7 [ Time Frame: over 72 hours after dosing on Day 7 ]
  • Metabolite PCI-45227 urine concentrations after administration on Day 1 [ Time Frame: over 72 hours after dosing on Day 1 ]
  • Metabolite PCI-45227 urine concentrations after administration on Day 7 [ Time Frame: over 72 hours after dosing on Day 7 ]
  • Incidence of adverse events as a measure of safety and tolerability [ Time Frame: Approximately 41 days ]

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   (Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01626651     History of Changes
Other Study ID Numbers: CR100870
PCI-32765CLL1002 ( Other Identifier: Janssen Research & Development, LLC )
Study First Received: June 18, 2012
Last Updated: June 18, 2013

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

Additional relevant MeSH terms:
Ketoconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors

ClinicalTrials.gov processed this record on June 22, 2017