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An Open-Label Phase 1 Study to Determine the Pharmacokinetics, Metabolism, and Routes of Excretion of (14C) Radiolabeled PCI-32765 in Healthy Male Subjects


Phase 1
30 Years
55 Years
Not Enrolling
Male
Healthy Participants

Thank you

Trial Information

An Open-Label Phase 1 Study to Determine the Pharmacokinetics, Metabolism, and Routes of Excretion of (14C) Radiolabeled PCI-32765 in Healthy Male Subjects


This is an open-label (all people know the identity of the intervention), single-center,
single-dose study in healthy male participants. Six men will be enrolled to allow a minimum
of 4 participants to complete the study. All participants will receive a single oral
solution dose of 50 to 140 mg ibrutinib containing 1480 kBq (40 µCi) of 14C labeled
ibrutinib, constituting a total radiation burden of approximately 0.916 mSv (ICRP risk
category IIa). The duration of the study is approximately 73 days including screening period
of 28 days, treatment period of 15 days, and follow-up period of 30 days. Safety will
include adverse events, laboratory safety, 12 lead electrocardiogram, physical examination,
and vital signs.


Inclusion Criteria:



- Participant must sign an informed consent document indicating they understand the
purpose of and procedures required for the study, including DNA analysis, and are
willing to participate in the study

- Must agree to use an adequate contraception method as deemed appropriate by the
investigator (eg, vasectomy, double-barrier, partner using effective contraception)
during the study and for 3 months after receiving the study drug

- Must agree to not donate sperm during the study and for 3 months after receiving the
study drug

- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140
mmHg systolic, inclusive, and no higher than 90 mmHg diastolic

- Non-smoker (not smoked for 6 months prior to screening)

Exclusion Criteria:

- History of or current clinically significant medical illness including cardiac
arrhythmias or other cardiac disease, hematologic disease, coagulation disorders,
lipid abnormalities, significant pulmonary disease, including bronchospastic
respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid
disease, neurologic or psychiatric disease

- Clinically significant abnormal values for hematology, coagulation and platelet
function, clinical chemistry or urinalysis at screening as deemed appropriate by the
investigator

- Clinically significant abnormal physical examination, vital signs or 12 lead
electrocardiogram (ECG) at screening as deemed appropriate by the investigator

- History of clinically significant allergies, especially known hypersensitivity or
intolerance to β-lactam antibiotics or sulfonamides

- Known allergy to heparin or history of heparin induced thrombocytopenia

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum concentration (Cmax) of ibrutinib

Outcome Description:

Pharmacokinetic parameter Cmax of ibrutinib will be determined.

Outcome Time Frame:

Day 1 (Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours)

Safety Issue:

No

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

CR100885

NCT ID:

NCT01674322

Start Date:

August 2012

Completion Date:

September 2012

Related Keywords:

  • Healthy Participants
  • Healthy participants
  • Ibrutinib
  • PCI-32765
  • B-cell malignancies
  • CYP3A4

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