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Healthy VolunteersPhase 1NCT01820936

A Study to Determine the Effect of Food on the Pharmacokinetics of PCI-32765

A Phase 1 study testing Sequence 1: PCI-32765, Sequence 2: PCI-32765 and Sequence 3: PCI-32765 in people with Healthy Volunteers, run by Janssen Research & Development, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the effect of food and two modified fasting regimens on the pharmacokinetics (study of what the body does to a drug) of PCI-32765 in healthy adult participants. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Healthy Volunteers
What is being tested?
Sequence 1: PCI-32765, Sequence 2: PCI-32765 and Sequence 3: PCI-32765
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
Mar 2013to Jun 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women must be postmenopausal or documented as surgically sterile
  • Men must agree to use an adequate contraception method as deemed appropriate by the investigator during the study and for 3 months after receiving the last dose of study drug, and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
  • Body mass index between 18 and 30 kg/m2and body weight not less than 50 kg
  • Blood pressure (after sitting for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic

Who cannot join

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, history of immune disorders (eg, lupus, rheumatoid arthritis, psoriatic arthritis) or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for hematology, coagulation, PFA-100, clinical chemistry or urinalysis at screening
  • Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) at screening
  • Use of aspirin, non-steroidal anti-inflammatory agents, clopidogrel, Vitamin E supplements, fish oil, or flax seed within 1 week before PFA-100 assay test at screening
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, and hormonal replacement therapy, within 14 days before the first dose of the study drug is scheduled
  • Use of herbal supplements (such as St. John's Wort) within 30 days of the first dose administration
Show all 16Show fewer
  • Has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 2 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening and Day -1 of each treatment period
  • History of clinically significant allergies, especially known hypersensitivity or intolerance to sulfonamide or beta-lactam antibiotics
  • Known allergy to the study drug or any of the excipients of the formulation
  • Known allergy to heparin or history of heparin induced thrombocytopenia
  • Donated blood or blood products or had substantial loss of blood within 3 months before the first administration of study drug or intention to donate blood or blood products during the study
  • Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half life, whichever is longer, before the first dose of the study drug is scheduled
  • Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
  • Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies
  • History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or participant's verbal report and confirmed by cotinine test
  • Preplanned surgery or procedures that would interfere with the conduct of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    Neptune City, New Jersey

Other trials in United States

About this study

Official title: Open-Label, Randomized, 4-Way Crossover Study to Determine the Effect of Food on the Pharmacokinetics of PCI-32765

The purpose of this study is to compare the effect of food and two modified fasting regimens on the pharmacokinetics (study of what the body does to a drug) of PCI-32765 in healthy adult participants.

Read the detailed description

This is a randomized (individuals will be assigned by chance to study treatments), open-label (identity of assigned study drug will be known), 4-way crossover study to compare the effect of food and two fasting regimens on the pharmacokinetics of PCI-32765 in healthy adults. There will be approximately 52 (at least 25% women) participants (11 in each sequence in the 4-way crossover and 8 in an optional cohort). A screening phase will be followed by an open-label treatment phase consisting of 4 single-dose treatment periods of 420 mg PCI-32765 administered with or without food. Doses in successive open-label treatment periods will be separated by a washout period of 7 days. Participants will be confined to the study center from Day -1 of each treatment period (at least 10 hours before each study drug administration) until completion of the 72 hour pharmacokinetic blood sample collection on Day 4 of Period 4. Blood samples for pharmacokinetic analysis of PCI-32765 and metabolite PCI-45227 will be collected before dosing and over 72 hours after dosing in each treatment period. A follow-up visit approximately 10 days after the last dose will be made to measure lymphocyte count and to capture any additional adverse events. After completion of the 4-way crossover portion of the study, and in absence of significant safety observations at the 420 mg PCI-32765 dose, an additional separate cohort of 8 participants may be enrolled to participate in one treatment period and receive a dose of 840 mg in combination with a high-fat breakfast. Safety will be assessed throughout the study. The total study duration is a maximum of 85 days.

Being tested
Sequence 1: PCI-32765, Sequence 2: PCI-32765, Sequence 3: PCI-32765, Sequence 4: PCI-32765, Sequence 5: PCI-32765
Keywords
Healthy volunteers, PCI-32765, PCI-45227, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sequence 1: PCI-32765Drug

    Period 1 = Treatment D, Period 2 = Treatment C, Period 3 = Treatment A, Period 4 = Treatment B

  • Sequence 2: PCI-32765Drug

    Period 1 = Treatment A, Period 2 = Treatment D, Period 3 = Treatment B, Period 4 = Treatment C

  • Sequence 3: PCI-32765Drug

    Period 1 = Treatment B, Period 2 = Treatment A, Period 3 = Treatment C, Period 4 = Treatment D

  • Sequence 4: PCI-32765Drug

    Period 1 = Treatment C, Period 2 = Treatment B, Period 3 = Treatment D, Period 4 = Treatment A

  • Sequence 5: PCI-32765Drug

    After completion of the 4-way crossover, an additional separate cohort of 8 subjects were enrolled. These subjects participated in 1 treatment period to document safety and PK

Study groups in NCT01820936
Study groupRoleWhat they receive
Treatment A: PCI-32765Experimental420 mg capsules administered by mouth with 240 mL noncarbonated water 30 minutes after completing a high-fat breakfast
Receives: Drug: Sequence 1: PCI-32765; Drug: Sequence 2: PCI-32765; Drug: Sequence 3: PCI-32765; Drug: Sequence 4: PCI-32765
Treatment B: PCI-32765Experimental420 mg capsules administered by mouth with 240 mL noncarbonated water after fasting for at least 10 hours and 30 minutes before starting a high-fat breakfast
Receives: Drug: Sequence 1: PCI-32765; Drug: Sequence 2: PCI-32765; Drug: Sequence 3: PCI-32765; Drug: Sequence 4: PCI-32765
Treatment C: PCI-32765Experimental420 mg capsules administered by mouth with 240 mL noncarbonated water 2 hours after completing a high-fat breakfast
Receives: Drug: Sequence 1: PCI-32765; Drug: Sequence 2: PCI-32765; Drug: Sequence 3: PCI-32765; Drug: Sequence 4: PCI-32765
Treatment D: PCI-32765Experimental420 mg capsules administered with 240 mL noncarbonated water after fasting at least 10 hours
Receives: Drug: Sequence 1: PCI-32765; Drug: Sequence 2: PCI-32765; Drug: Sequence 3: PCI-32765; Drug: Sequence 4: PCI-32765
Treatment E: PCI-32765Experimental840 mg capsules administered with 240mL noncarbonated water 30 minutes after completing a high-fat breakfast
Receives: Drug: Sequence 5: PCI-32765

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentrations of PCI-32765

    Measured: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours

  2. Area under the plasma concentration-time curve from time 0 to infinite time of PCI-32765

    Measured: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours

  3. Maximum plasma concentration of PCI-32765

    Measured: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours

Secondary outcomes (13)

  1. Time to reach the maximum plasma concentration of PCI-32765

    Measured: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours

  2. Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of PCI-32765

    Measured: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours

  3. Elimination half-life of PCI-32765

    Measured: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours

  4. Relative bioavailability of PCI-32765

    Relative bioavailability is defined as the ratio of the area under the concentration curve to infinity between the test treatment and the reference treatment.

    Measured: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours

  5. Maximum plasma concentration of metabolite PCI-45227

    Measured: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours

  6. Time to reach the maximum plasma concentration of metabolite PCI-45227

    Measured: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours

  7. Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentrations of metabolite PCI-45227

    Measured: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours

  8. Area under the plasma concentration-time curve from time 0 to infinite time of metabolite PCI-45227

    Measured: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours

  9. Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of metabolite PCI-45227

    Measured: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours

  10. Elimination half-life of metabolite PCI-45227

    Measured: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours

  11. Relative bioavailability of metabolite PCI-45227

    Measured: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours

  12. Number of participants with adverse events

    Measured: Up to 30 days following the last dose of study drug

  13. Number of participants with adverse events of special interest (major hemorrhage and intracranial hemorrhage)

    Measured: Up to 30 days following the last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01820936
Sponsor's protocol ID
CR101204
Other IDs
PCI-32765CLL1001, 2013-000963-96
Status last verified
Jul 2014
First submitted
4 Mar 2013
Last updated
15 Jul 2014
Results posted
No
Data monitoring committee
No

Publications

  • de Jong J, Sukbuntherng J, Skee D, Murphy J, O'Brien S, Byrd JC, James D, Hellemans P, Loury DJ, Jiao J, Chauhan V, Mannaert E. The effect of food on the pharmacokinetics of oral ibrutinib in healthy participants and patients with chronic lymphocytic leukemia. Cancer Chemother Pharmacol. 2015 May;75(5):907-16. doi: 10.1007/s00280-015-2708-9. Epub 2015 Feb 28.

    PubMed 25724156

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sequence 1: PCI-32765, Sequence 2: PCI-32765 and Sequence 3: PCI-32765 in people with Healthy Volunteers, run by Janssen Research & Development, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentrations of PCI-32765 (time frame: Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01820936, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.

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