HealthyPhase 1NCT02271438
A Study to Evaluate the Effects of Ibrutinib on Cardiac Repolarization in Healthy Participants
A Phase 1 study testing Ibrutinib and Moxifloxacin in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the safety and tolerability of ibrutinib, to compare the pharmacokinetics of ibrutinib after single oral administration of 840 mg and 1680 mg and to assess the effects of a single dose of ibrutinib on QT/QTc intervals and electrocardiogram (ECG) in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ibrutinib and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to May 2015
- 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
- Must sign an informed consent document indicating they understand the purpose of the study and procedures
- Must have a body mass index (BMI) of between 18 and 30 kg/m^2, inclusive
- Must have a body weight of not less than 50 kg
- Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
- Must have an average of triplicate 12-lead ECG recordings, completed within 5 minutes total, consistent with normal cardiac conduction and function
Who cannot join
- History of or current clinically significant medical illness
- Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram
- History of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardias, and heart blocks
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements
- Donated blood or blood products or had substantial loss of blood within 3 months before screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo- and Positive-Controlled, Single-Dose, Four-Way Crossover Study to Evaluate the Effects of Ibrutinib on Cardiac Repolarization in Healthy Subjects
The purpose of this study is to assess the safety and tolerability of ibrutinib, to compare the pharmacokinetics of ibrutinib after single oral administration of 840 mg and 1680 mg and to assess the effects of a single dose of ibrutinib on QT/QTc intervals and electrocardiogram (ECG) in healthy adults.
Read the detailed description
The study consists of 2 parts: Part 1 and Part 2. Part 1 is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving), single-center, 2-period, sequential design part. It consists of a Screening phase (Day-21 to -2), Treatment Period 1 and Treatment Period 2. In treatment period 1, 8 participants including two women will receive 840 milligram (mg) ibrutinib capsules + 6 placebo capsules. In treatment period 2, participants will receive 1680 mg ibrutinib capsules. Treatment periods will be separated by a Washout period of not less than 7 days. A high-fat breakfast will be provided 2 hours before dosing. Blood samples will be collected after each dosing for pharmacokinetic assessments.
Part 2 is a randomized (the study medication is assigned by chance), placebo (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) and positive-controlled (participants are assigned to either a recognized effective treatment or the study medication), double-blind (neither physician nor participant knows the treatment that the participant receives), single dose, and 4-way crossover (the same medications are provided to all participants but in a different sequence) part. Participants will receive either of the 4 treatments: Treatment A (Ibrutinib 1680 mg + moxifloxacin-matching placebo); Treatment B (Ibrutinib 840 mg+ ibrutinib-matching placebo + moxifloxacin-matching placebo); Treatment C (ibrutinib-matching placebo + moxifloxacin-matching placebo); and Treatment D: (moxifloxacin 400 mg + ibrutinib-matching placebo). Each treatment period will be separated by a Washout period of not less than 7 days. Electrocardiogram (ECG) will be recorded. Participants' safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- Ibrutinib, Moxifloxacin, Ibrutinib-matching placebo, Moxifloxacin-matching placebo
- Keywords
- Healthy, Ibrutinib, Moxifloxacin, Cardiac Repolarization, Electrocardiogram, QTc interval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Participants will receive a single oral dose of 12 capsules (12*140 mg capsules) of ibrutinib in Treatment A and 6 capsules (4 6*140 mg capsules) of ibrutinib in Treatment B.
MoxifloxacinDrug
Participants will receive a single oral dose of 1 moxifloxacin capsule (400 mg) in Treatment D.
Ibrutinib-matching placeboDrug
Participants will receive a single oral dose of 12 ibrutinib-matching placebo capsules in Treatment B and 6 ibrutinib-matching placebo capsules in Treatment C and D.
Moxifloxacin-matching placeboDrug
Participants will receive a single oral dose of 1 moxifloxacin-matching placebo capsule in Treatment A, B, and C.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Ibrutinib 840 milligram (mg) | Experimental | Participants will receive ibrutinib 840 mg (6*140 mg capsules) + 6 placebo capsules on Day 1 of Part 1, Period 1. Receives: Drug: Ibrutinib |
| Part 1: Ibrutinib 1680 mg | Experimental | Participants will receive ibrutinib 1680 mg (12*140 mg capsules) on Day 1 of Part 1, Period 2. Receives: Drug: Ibrutinib |
| Part 2: Treatment A | Experimental | Participants will receive ibrutinib, 1680 mg (12*140 mg capsules) + 1 moxifloxacin-matching placebo capsule Day 1of Part 2. Receives: Drug: Ibrutinib; Drug: Moxifloxacin-matching placebo |
| Part 2: Treatment B | Experimental | Participants will receive ibrutinib, 840 mg (6*140 mg capsules) + 6 ibrutinib-matching placebo capsules + 1 moxifloxacin-matching placebo capsule. Receives: Drug: Ibrutinib; Drug: Moxifloxacin-matching placebo |
| Part 2: Treatment C | Experimental | Participants will receive placebo (12 ibrutinib-matching placebo capsules + 1 moxifloxacin-matching placebo capsule) Day 1 of Part 2. Receives: Drug: Ibrutinib-matching placebo; Drug: Moxifloxacin-matching placebo |
| Part 2: Treatment D | Experimental | Participants will receive moxifloxacin 400 mg (1 capsule) + 12 ibrutinib-matching placebo capsules Day 1 of Part 2. Receives: Drug: Moxifloxacin; Drug: Ibrutinib-matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QTc interval
The QTc interval, as measured by electrocardiograms will evaluate the potential effect of ibrutinib on QTc interval duration.
Measured: Baseline (predose) up to Day 4
Number of Participants with Adverse events
Measured: Up to Day 12 of the follow-up period
Secondary outcomes (7)
Change from baseline in RR interval
The RR interval is the portion between two consecutive R waves in the electrocardiogram.
Measured: Baseline (predose) up to Day 4
Change from baseline in heart rate
Measured: Baseline (predose) up to Day 4
Change from baseline in PR interval
The PR interval is the portion of the electrocardiogram between the onset of the P wave (atrial depolarization) and the QRS complex (ventricular depolarization).
Measured: Baseline (predose) up to Day 4
Change from baseline in QRS interval
The QRS interval is the interval from the beginning of the Q wave to the termination of the S wave, representing the time for ventricular depolarization.
Measured: Baseline (predose) up to Day 4
Plasma concentration of ibrutinib following administration of a single dose
Plasma concentrations of ibrutinib are used to evaluate when the highest concentration is achieved in the body and how long it stays in the body.
Measured: Predose (before tablet intake), up to 72 hours after dose
Plasma concentration of the Metabolite, PCI-45227, following administration of a single dose of ibrutinib
Plasma concentrations of the metabolite, PCI-45227, are used to evaluate when the highest concentration is achieved in the body and how long it stays in the body.
Measured: Predose (before tablet intake), up to 72 hours after dose
Plasma concentration of moxifloxacin following administration of a single dose
Plasma concentrations of moxifloxacin are used to evaluate when the highest concentration is achieved in the body and how long it stays in the body.
Measured: Predose (before tablet intake), up to 72 hours after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271438
- Sponsor's protocol ID
- CR103807
- Other IDs
- PCI-32765CLL1007, 2014-000081-22, 2014
- Status last verified
- Jun 2016
- First submitted
- 20 Oct 2014
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
de Jong J, Hellemans P, Jiao JJ, Huang Y, Mesens S, Sukbuntherng J, Ouellet D. Ibrutinib does not prolong the corrected QT interval in healthy subjects: results from a thorough QT study. Cancer Chemother Pharmacol. 2017 Dec;80(6):1227-1237. doi: 10.1007/s00280-017-3471-x. Epub 2017 Oct 28.
PubMed 29080970
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Positive-Controlled, Single-Dose, Four-Way Crossover Study to Evaluate the Effects of Ibrutinib on Cardiac Repolarization in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02271438
- Acronym / sponsor ID
- CR103807
- Conditions
- Healthy
- Keywords
- Healthy, Ibrutinib, Moxifloxacin, Cardiac Repolarization, Electrocardiogram, QTc interval
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 22 Oct 2014 (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 assess the safety and tolerability of ibrutinib, to compare the pharmacokinetics of ibrutinib after single oral administration of 840 mg and 1680 mg and to assess the effects of a single dose of ibrutinib on QT/QTc intervals and electrocardiogram (ECG) in healthy adults.
Detailed description
The study consists of 2 parts: Part 1 and Part 2. Part 1 is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving), single-center, 2-period, sequential design part. It consists of a Screening phase (Day-21 to -2), Treatment Period 1 and Treatment Period 2. In treatment period 1, 8 participants including two women will receive 840 milligram (mg) ibrutinib capsules + 6 placebo capsules. In treatment period 2, participants will receive 1680 mg ibrutinib capsules. Treatment periods will be separated by a Washout period of not less than 7 days. A high-fat breakfast will be provided 2 hours before dosing. Blood samples will be collected after each dosing for pharmacokinetic assessments.
Part 2 is a randomized (the study medication is assigned by chance), placebo (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) and positive-controlled (participants are assigned to either a recognized effective treatment or the study medication), double-blind (neither physician nor participant knows the treatment that the participant receives), single dose, and 4-way crossover (the same medications are provided to all participants but in a different sequence) part. Participants will receive either of the 4 treatments: Treatment A (Ibrutinib 1680 mg + moxifloxacin-matching placebo); Treatment B (Ibrutinib 840 mg+ ibrutinib-matching placebo + moxifloxacin-matching placebo); Treatment C (ibrutinib-matching placebo + moxifloxacin-matching placebo); and Treatment D: (moxifloxacin 400 mg + ibrutinib-matching placebo). Each treatment period will be separated by a Washout period of not less than 7 days. Electrocardiogram (ECG) will be recorded. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: Ibrutinib 840 milligram (mg) | Experimental | Drug: IbrutinibParticipants will receive ibrutinib 840 mg (6*140 mg capsules) + 6 placebo capsules on Day 1 of Part 1, Period 1. |
| Part 1: Ibrutinib 1680 mg | Experimental | Drug: IbrutinibParticipants will receive ibrutinib 1680 mg (12*140 mg capsules) on Day 1 of Part 1, Period 2. |
| Part 2: Treatment A | Experimental | Drug: Ibrutinib, Drug: Moxifloxacin-matching placeboParticipants will receive ibrutinib, 1680 mg (12*140 mg capsules) + 1 moxifloxacin-matching placebo capsule Day 1of Part 2. |
| Part 2: Treatment B | Experimental | Drug: Ibrutinib, Drug: Moxifloxacin-matching placeboParticipants will receive ibrutinib, 840 mg (6*140 mg capsules) + 6 ibrutinib-matching placebo capsules + 1 moxifloxacin-matching placebo capsule. |
| Part 2: Treatment C | Experimental | Drug: Ibrutinib-matching placebo, Drug: Moxifloxacin-matching placeboParticipants will receive placebo (12 ibrutinib-matching placebo capsules + 1 moxifloxacin-matching placebo capsule) Day 1 of Part 2. |
| Part 2: Treatment D | Experimental | Drug: Moxifloxacin, Drug: Ibrutinib-matching placeboParticipants will receive moxifloxacin 400 mg (1 capsule) + 12 ibrutinib-matching placebo capsules Day 1 of Part 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must sign an informed consent document indicating they understand the purpose of the study and procedures
- Must have a body mass index (BMI) of between 18 and 30 kg/m^2, inclusive
- Must have a body weight of not less than 50 kg
- Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
- Must have an average of triplicate 12-lead ECG recordings, completed within 5 minutes total, consistent with normal cardiac conduction and function
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness
- Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram
- History of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardias, and heart blocks
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements
- Donated blood or blood products or had substantial loss of blood within 3 months before screening
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 |
|---|---|---|
| IbrutinibParticipants will receive a single oral dose of 12 capsules (12*140 mg capsules) of ibrutinib in Treatment A and 6 capsules (4 6*140 mg capsules) of ibrutinib in Treatment B. | Drug | Part 1: Ibrutinib 1680 mg, Part 1: Ibrutinib 840 milligram (mg), Part 2: Treatment A, Part 2: Treatment B |
| MoxifloxacinParticipants will receive a single oral dose of 1 moxifloxacin capsule (400 mg) in Treatment D. | Drug | Part 2: Treatment D |
| Ibrutinib-matching placeboParticipants will receive a single oral dose of 12 ibrutinib-matching placebo capsules in Treatment B and 6 ibrutinib-matching placebo capsules in Treatment C and D. | Drug | Part 2: Treatment C, Part 2: Treatment D |
| Moxifloxacin-matching placeboParticipants will receive a single oral dose of 1 moxifloxacin-matching placebo capsule in Treatment A, B, and C. | Drug | Part 2: Treatment A, Part 2: Treatment B, Part 2: Treatment C |
Primary outcome
Change from baseline in QTc interval
Time frame: Baseline (predose) up to Day 4
The QTc interval, as measured by electrocardiograms will evaluate the potential effect of ibrutinib on QTc interval duration.
Number of Participants with Adverse events
Time frame: Up to Day 12 of the follow-up period
7 secondary outcomes
Change from baseline in RR interval
Time frame: Baseline (predose) up to Day 4
Change from baseline in heart rate
Time frame: Baseline (predose) up to Day 4
Change from baseline in PR interval
Time frame: Baseline (predose) up to Day 4
Change from baseline in QRS interval
Time frame: Baseline (predose) up to Day 4
Plasma concentration of ibrutinib following administration of a single dose
Time frame: Predose (before tablet intake), up to 72 hours after dose
Plasma concentration of the Metabolite, PCI-45227, following administration of a single dose of ibrutinib
Time frame: Predose (before tablet intake), up to 72 hours after dose
Plasma concentration of moxifloxacin following administration of a single dose
Time frame: Predose (before tablet intake), up to 72 hours after dose
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 6 Jun 2016.
- Derived from this study: PubMed 29080970de Jong J, Hellemans P, Jiao JJ, Huang Y, Mesens S, Sukbuntherng J, Ouellet D. Ibrutinib does not prolong the corrected QT interval in healthy subjects: results from a thorough QT study. Cancer Chemother Pharmacol. 2017 Dec;80(6):1227-1237. doi: 10.1007/s00280-017-3471-x. Epub 2017 Oct 28.
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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 Ibrutinib and Moxifloxacin in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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 5 inclusion and 5 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 6 Jun 2016. 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 Belgium. 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?
Change from baseline in QTc interval (time frame: Baseline (predose) up to Day 4). 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?
On the ClinicalTrials.gov record for NCT02271438, 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 6 Jun 2016.