A Study to Determine the Absorption, Metabolism, and Routes of Excretion of (14C) Radiolabeled Ibrutinib in Healthy Male Participants
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ClinicalTrials.gov Identifier: NCT01674322 |
Recruitment Status :
Completed
First Posted : August 28, 2012
Last Update Posted : November 5, 2014
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Condition or disease | Intervention/treatment | Phase |
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Healthy Participants | Drug: Ibrutinib | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Phase 1 Study to Determine the Pharmacokinetics, Metabolism, and Routes of Excretion of (14C) Radiolabeled PCI-32765 in Healthy Male Subjects |
Study Start Date : | August 2012 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Ibrutinib
All participants will receive a single oral solution dose of 50 mg to 140 mg -ibrutinib containing 1480 kBq (40 µCi) of 14C-labeled ibrutinib, with a total radiation burden of approximately 0.916 mSv.
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Drug: Ibrutinib
Type=exact number, unit=mg, number=50-140, form=solution, route=oral. Participants will receive a single oral solution dose of 50 mg to 140 mg -ibrutinib containing 1480 kBq (40 µCi) of 14C-labeled ibrutinib, with a total radiation burden of approximately 0.916 mSv.
Other Name: PCI-32765 |
- Maximum concentration (Cmax) of ibrutinib [ 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) ]Pharmacokinetic parameter Cmax of ibrutinib will be determined.
- Time to reach the maximum concentration (tmax) of ibrutinib [ Time Frame: Predose, Day 1 (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) ]Pharmacokinetic parameter tmax of ibrutinib will be determined.
- Area under the concentration-time curve (AUC) of ibrutinib [ Time Frame: Predose, Day 1 (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) ]Pharmacokinetic parameter AUC of ibrutinib will be determined.
- Amount excreted into the urine (Ae) of ibrutinib [ Time Frame: Day -1, Day 1 over intervals 0-2, 2-4, 4-8, 8-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168 hours, Days 9-15 ]Pharmacokinetic parameter Ae of ibrutinib will be determined by multiplying the urinary volume with the urinary concentration.
- Number of patients with adverse events [ Time Frame: Up to 73 days ]

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Ages Eligible for Study: | 30 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674322
Belgium | |
Merksem, Belgium |
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT01674322 |
Other Study ID Numbers: |
CR100885 PCI-32765CLL1004 ( Other Identifier: Janssen Research & Development, LLC ) 2012-002087-27 ( EudraCT Number ) |
First Posted: | August 28, 2012 Key Record Dates |
Last Update Posted: | November 5, 2014 |
Last Verified: | November 2014 |
Healthy participants Ibrutinib PCI-32765 B-cell malignancies CYP3A4 |