NCT01820936

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

3 months

First QC Date

March 4, 2013

Last Update Submit

July 14, 2014

Conditions

Healthy Volunteers

Keywords

Healthy volunteersPCI-32765PCI-45227Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

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

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

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

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

  • Maximum plasma concentration of PCI-32765

    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)

  • Time to reach the maximum plasma concentration of PCI-32765

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

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

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

  • Elimination half-life of PCI-32765

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

  • Relative bioavailability of PCI-32765

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

  • Maximum plasma concentration of metabolite PCI-45227

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

  • +8 more secondary outcomes

Study Arms (5)

Treatment A: PCI-32765

EXPERIMENTAL

420 mg capsules administered by mouth with 240 mL noncarbonated water 30 minutes after completing a high-fat breakfast

Drug: Sequence 1: PCI-32765Drug: Sequence 2: PCI-32765Drug: Sequence 3: PCI-32765Drug: Sequence 4: PCI-32765

Treatment B: PCI-32765

EXPERIMENTAL

420 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

Drug: Sequence 1: PCI-32765Drug: Sequence 2: PCI-32765Drug: Sequence 3: PCI-32765Drug: Sequence 4: PCI-32765

Treatment C: PCI-32765

EXPERIMENTAL

420 mg capsules administered by mouth with 240 mL noncarbonated water 2 hours after completing a high-fat breakfast

Drug: Sequence 1: PCI-32765Drug: Sequence 2: PCI-32765Drug: Sequence 3: PCI-32765Drug: Sequence 4: PCI-32765

Treatment D: PCI-32765

EXPERIMENTAL

420 mg capsules administered with 240 mL noncarbonated water after fasting at least 10 hours

Drug: Sequence 1: PCI-32765Drug: Sequence 2: PCI-32765Drug: Sequence 3: PCI-32765Drug: Sequence 4: PCI-32765

Treatment E: PCI-32765

EXPERIMENTAL

840 mg capsules administered with 240mL noncarbonated water 30 minutes after completing a high-fat breakfast

Drug: Sequence 5: PCI-32765

Interventions

Sequence 1: PCI-32765DRUG

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

Treatment A: PCI-32765Treatment B: PCI-32765Treatment C: PCI-32765Treatment D: PCI-32765
Sequence 2: PCI-32765DRUG

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

Treatment A: PCI-32765Treatment B: PCI-32765Treatment C: PCI-32765Treatment D: PCI-32765
Sequence 3: PCI-32765DRUG

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

Treatment A: PCI-32765Treatment B: PCI-32765Treatment C: PCI-32765Treatment D: PCI-32765
Sequence 4: PCI-32765DRUG

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

Treatment A: PCI-32765Treatment B: PCI-32765Treatment C: PCI-32765Treatment D: PCI-32765
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

Treatment E: PCI-32765

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neptune City, New Jersey, United States

Location

Related Publications (1)

  • 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.

    PMID: 25724156DERIVED

Related Links

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 29, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations

US(1)