Healthy VolunteerPhase 1NCT01969266
A Pharmacokinetic Study in Healthy Participants to Assess the Pharmacokinetics and Safety of a Supratherapeutic Dose of PCI-32765 (Ibrutinib) Capsule and Solution Formulations Administered With Food
A Phase 1 study testing Treatment A: PCI-32765 and Treatment B: PCI-32765 in people with Healthy Volunteer, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to examine the exposure and safety of a supratherapeutic dose of PCI-32765 (ibrutinib) in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Treatment A: PCI-32765 and Treatment B: PCI-32765
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Nov 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women must be postmenopausal or surgically sterile
- A sexually active man with a woman of child-bearing potential that has not had a vasectomy must agree to use an adequate contraception method 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/m2 and body weight not less than 50 kg
- Blood pressure (after sitting for 5 minutes) between 90 and 140 mmHg systolic, and no higher than 90 mmHg diastolic
- 12-lead ECG consistent with normal cardiac conduction and function
- Non-smoker
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, 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, or any other illness the investigator considers should exclude the participant or could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, coagulation, PFA 100, clinical chemistry, or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
- 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 study drug administration
- 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 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
Show all 15Show fewer
- Known allergy to the study drug or any of the excipients of the formulation
- Donated blood or blood products or had substantial loss of blood (more than 500 mL) 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
- A woman that is pregnant, breast-feeding or planning to become pregnant during the study
- A man who plans to father a child while enrolled in the study or within 3 months after the last dose of study drug
- Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies
- History of smoking or use of nicotine-containing substances within the previous 2 months, or positive cotinine test at screening
- Preplanned surgery or procedures that would interfere with the conduct of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, 2-Period, Sequential Design, Exploratory Pharmacokinetic Study In Healthy Subjects to Assess the Pharmacokinetics and Safety of a Supra-Therapeutic Dose of Ibrutinib Capsule and Solution Formulations Administered With Food
The purpose of this study is to examine the exposure and safety of a supratherapeutic dose of PCI-32765 (ibrutinib) in healthy adult volunteers.
Read the detailed description
This is an open-label (identity of assigned study drug will be known), 2-period, sequential, exploratory study in healthy adult men and women to determine the exposure and safety of a supratherapeutic dose of PCI-32765 (ibrutinib) as a capsule or solution formulation administered with food. Eight participants (including at least 2 women) will be enrolled and receive 2 treatments: PCI-32765 840 mg will be administered as capsule (Treatment A in Period 1) and solution (Treatment B in Period 2) formulations. All participants will receive both treatments with a 7-day washout period between doses. A high-fat breakfast will be provided 2 hours before dosing. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected before dosing and over 72 hours after each dose and safety will be monitored throughout the study. The total duration of the study will be approximately 46 days.
- Conditions
- Healthy Volunteer
- Being tested
- Treatment A: PCI-32765, Treatment B: PCI-32765
- Keywords
- Healthy volunteer, PCI-32765, PCI 45227, JNJ-54179060, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A: PCI-32765Drug
840 mg capsule formulation administered by mouth on Day 1
Treatment B: PCI-32765Drug
840 mg solution formulation administered by mouth on Day 1
| Study group | Role | What they receive |
|---|---|---|
| PCI-32765 | Experimental | PCI-32765 840 mg will be administered as capsule (Treatment A in Period 1) and solution (Treatment B in Period 2) formulations. All participants will receive both treatments with a 7-day washout period between doses. Receives: Drug: Treatment A: PCI-32765; Drug: Treatment B: PCI-32765 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentrations of ibrutinib and metabolite PCI-45227
Measured: Up to postdose at 72 h
Area under the plasma concentration-time curve of ibrutinib and metabolite PCI-45227
Measured: Up to postdose at 72 h
Secondary outcomes (1)
Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
Measured: Up to 30 days after the last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmacyclics LLC.
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969266
- Sponsor's protocol ID
- CR102577
- Other IDs
- PCI-32765CLL1008
- Status last verified
- Feb 2014
- First submitted
- 19 Aug 2013
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, 2-Period, Sequential Design, Exploratory Pharmacokinetic Study In Healthy Subjects to Assess the Pharmacokinetics and Safety of a Supra-Therapeutic Dose of Ibrutinib Capsule and Solution Formulations Administered With Food
- ClinicalTrials.gov ID
- NCT01969266
- Acronym / sponsor ID
- CR102577
- Conditions
- Healthy Volunteer
- Keywords
- Healthy volunteer, PCI-32765, PCI 45227, JNJ-54179060, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Pharmacyclics LLC.
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the exposure and safety of a supratherapeutic dose of PCI-32765 (ibrutinib) in healthy adult volunteers.
Detailed description
This is an open-label (identity of assigned study drug will be known), 2-period, sequential, exploratory study in healthy adult men and women to determine the exposure and safety of a supratherapeutic dose of PCI-32765 (ibrutinib) as a capsule or solution formulation administered with food. Eight participants (including at least 2 women) will be enrolled and receive 2 treatments: PCI-32765 840 mg will be administered as capsule (Treatment A in Period 1) and solution (Treatment B in Period 2) formulations. All participants will receive both treatments with a 7-day washout period between doses. A high-fat breakfast will be provided 2 hours before dosing. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected before dosing and over 72 hours after each dose and safety will be monitored throughout the study. The total duration of the study will be approximately 46 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCI-32765 | Experimental | Drug: Treatment A: PCI-32765, Drug: Treatment B: PCI-32765PCI-32765 840 mg will be administered as capsule (Treatment A in Period 1) and solution (Treatment B in Period 2) formulations. All participants will receive both treatments with a 7-day washout period between doses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women must be postmenopausal or surgically sterile
- A sexually active man with a woman of child-bearing potential that has not had a vasectomy must agree to use an adequate contraception method 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/m2 and body weight not less than 50 kg
- Blood pressure (after sitting for 5 minutes) between 90 and 140 mmHg systolic, and no higher than 90 mmHg diastolic
- 12-lead ECG consistent with normal cardiac conduction and function
Key exclusion criteria (15 listed)
- History of or current clinically significant medical illness including (but not limited to) 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, infection, history of immune disorders, or any other illness the investigator considers should exclude the participant or could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, coagulation, PFA 100, clinical chemistry, or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
- 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 study drug administration
- 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 at screening and Day -1 of each treatment period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment A: PCI-32765840 mg capsule formulation administered by mouth on Day 1 | Drug | PCI-32765 |
| Treatment B: PCI-32765840 mg solution formulation administered by mouth on Day 1 | Drug | PCI-32765 |
Primary outcome
Maximum observed plasma concentrations of ibrutinib and metabolite PCI-45227
Time frame: Up to postdose at 72 h
Area under the plasma concentration-time curve of ibrutinib and metabolite PCI-45227
Time frame: Up to postdose at 72 h
1 secondary outcome
Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
Time frame: Up to 30 days after the last dose of study medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A: PCI-32765 and Treatment B: PCI-32765 in people with Healthy Volunteer, 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 6 inclusion and 15 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 13 Feb 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?
Maximum observed plasma concentrations of ibrutinib and metabolite PCI-45227 (time frame: Up to postdose at 72 h). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2014.