HealthyPhase 1NCT02390609
A Crossover Study to Evaluate the Bioavailability of Ibrutinib Suspension and Sprinkle Formulations Compared to Capsules in Healthy Adults
A Phase 1 study testing Ibrutinib (Treatment A) [Reference], Ibrutinib (Treatment B) and Ibrutinib (Treatment C) 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 relative bioavailability (the extent to which a drug or other substance becomes available to the body) of ibrutinib in healthy adults following single oral dose administration of suspension and sprinkle formulations under fed and fasted conditions compared with capsules under… 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 (Treatment A) [Reference], Ibrutinib (Treatment B) and Ibrutinib (Treatment C)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2015to Nov 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
- Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
- If a woman, must not be of childbearing potential: postmenopausal ( greater than [>] 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) >40 International units [IU]/ Liter [L]); surgically sterile
- If a woman, must have a negative serum β-human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test on Day-1 of the each treatment period
- If a man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Body mass index (BMI; weight [kg]/height^2 [m]^2) between 18 and 30 Kilogram (kg)/ meter^2 (m^2) (inclusive), and body weight not less than 50 kg
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, hepatic or renal insufficiency (creatinine clearance below 60 milliliter [mL]/ minute [min]), thyroid disease, neurologic or psychiatric disease, infection, 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, clinical chemistry, 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
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled until completion of the study
- 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 the each treatment period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Randomized, Parallel Group, 3- or 4-Way Crossover Bioavailability Study of Ibrutinib Suspension and Sprinkle Formulations Compared to Capsules in Healthy Adults
The purpose of this study is to assess the relative bioavailability (the extent to which a drug or other substance becomes available to the body) of ibrutinib in healthy adults following single oral dose administration of suspension and sprinkle formulations under fed and fasted conditions compared with capsules under fasted conditions.
Read the detailed description
This is an open-label (all people know the identity of the intervention), randomized (study medication assigned to participants by chance), 3- or 4-way crossover (participants may receive different interventions sequentially during the trial), and single-center study of ibrutinib. The duration of study will be approximately 67 to 83 days per participant. The study consists of 3 parts: Screening (28 days before study commences on Day 1); Open-label Treatment (consists of 6 treatments, either Ibrutinib capsule or suspension or sprinkle capsule granules under fed or fasted condition), in subsequent 3 periods for Group 1 and 4 periods for Group 2, each separated with washout period of 7 (plus [+] / minus [-] 2) days; and follow up Phase (up to 10 + / - 2 days after last study drug administration). All the eligible participants will be randomly assigned to 1 of the 6 (Group 1) or 4 (Group 2) treatment sequences. In fasted conditions, study drug will be administered following a 10-hour overnight fast. In fed conditions, participants will also fast from food for 10 hours, but will consume a high fat breakfast within a 30-minute period. Study drug will be administered 2 hours after the breakfast. Participants will not be allowed to have food until 4 hours of drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of Ibrutinib will be evaluated primarily. Participants' safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- Ibrutinib (Treatment A) [Reference], Ibrutinib (Treatment B), Ibrutinib (Treatment C), Ibrutinib (Treatment D), Ibrutinib (Treatment E)
- Keywords
- Healthy, Ibrutinib, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibrutinib (Treatment A) [Reference]Drug
Participants will receive Ibrutinib 560 milligram (mg) (4*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.
Ibrutinib (Treatment B)Drug
Participants will receive Ibrutinib 560 mg suspension as Treatment B under fasted conditions in one of the treatment periods.
Ibrutinib (Treatment C)Drug
Participants will receive Ibrutinib 560 mg suspension as Treatment C under fed (high-fat) conditions in one of the treatment periods.
Ibrutinib (Treatment D)Drug
Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment D under fasted conditions in one of the treatment periods.
Ibrutinib (Treatment E)Drug
Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment E under fed (high-fat) conditions in one of the treatment periods.
Ibrutinib (Treatment F)Drug
Participants will receive Ibrutinib 560 mg sprinkle capsule granules suspended in water as Treatment F under fasted conditions in one of the treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Sequence 1 (ABC) | Experimental | Participants will receive Treatment A (Ibrutinib 560 milligram [mg] capsules [reference] under fasted conditions) in Period 1; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 2; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 3. A washout period of 7 (plus [+] / minus [-] 2) days will be maintained between each treatment period. Receives: Drug: Ibrutinib (Treatment A) [Reference]; Drug: Ibrutinib (Treatment B); Drug: Ibrutinib (Treatment C) |
| Group 1: Sequence 2 (BCA) | Experimental | Participants will receive Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 1; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 2; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period. Receives: Drug: Ibrutinib (Treatment A) [Reference]; Drug: Ibrutinib (Treatment B); Drug: Ibrutinib (Treatment C) |
| Group 1: Sequence 3 (CAB) | Experimental | Participants will receive Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 1; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 2; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period. Receives: Drug: Ibrutinib (Treatment A) [Reference]; Drug: Ibrutinib (Treatment B); Drug: Ibrutinib (Treatment C) |
| Group 1: Sequence 4 (ACB) | Experimental | Participants will receive Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 1; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 2; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period. Receives: Drug: Ibrutinib (Treatment A) [Reference]; Drug: Ibrutinib (Treatment B); Drug: Ibrutinib (Treatment C) |
| Group 1: Sequence 5 (BAC) | Experimental | Participants will receive Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 1; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 2; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period. Receives: Drug: Ibrutinib (Treatment A) [Reference]; Drug: Ibrutinib (Treatment B); Drug: Ibrutinib (Treatment C) |
| Group 1: Sequence 6 (CBA) | Experimental | Participants will receive Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 1; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 2; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period. Receives: Drug: Ibrutinib (Treatment A) [Reference]; Drug: Ibrutinib (Treatment B); Drug: Ibrutinib (Treatment C) |
| Group 2: Sequence 1 (AFDE) | Experimental | Participants will receive Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 1; followed by Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 2; followed by Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 3; followed by Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period. Receives: Drug: Ibrutinib (Treatment A) [Reference]; Drug: Ibrutinib (Treatment D); Drug: Ibrutinib (Treatment E); Drug: Ibrutinib (Treatment F) |
| Group 2: Sequence 2 (DAEF) | Experimental | Participants will receive Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 1; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 2; followed by Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 3; followed by Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period. Receives: Drug: Ibrutinib (Treatment A) [Reference]; Drug: Ibrutinib (Treatment D); Drug: Ibrutinib (Treatment E); Drug: Ibrutinib (Treatment F) |
| Group 2: Sequence 3 (EDFA) | Experimental | Participants will receive Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 1; followed by Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 2; followed by Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 3; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period. Receives: Drug: Ibrutinib (Treatment A) [Reference]; Drug: Ibrutinib (Treatment D); Drug: Ibrutinib (Treatment E); Drug: Ibrutinib (Treatment F) |
| Group 2: Sequence 4 (FEAD) | Experimental | Participants will receive Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 1; followed by Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 2; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 3; followed by Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period. Receives: Drug: Ibrutinib (Treatment A) [Reference]; Drug: Ibrutinib (Treatment D); Drug: Ibrutinib (Treatment E); Drug: Ibrutinib (Treatment F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Ibrutinib
The Cmax is the maximum observed plasma concentration of Ibrutinib.
Measured: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
Time to Reach the Maximum Plasma Concentration (Tmax) of Ibrutinib
The Tmax is the time to reach the maximum observed plasma concentration of Ibrutinib.
Measured: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of Ibrutinib
The AUC (0-24hrs) is the area under the plasma Ibrutinib concentration-time curve from 0 to 24 hours post dosing.
Measured: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (AUC [0-last]) of Ibrutinib
The AUC (0-last) is the area under the plasma Ibrutinib concentration-time curve from time 0 to time of the last observed quantifiable concentration (C[last]).
Measured: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of Ibrutinib
The AUC (0-infinity) is the area under the plasma Ibrutinib concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma Ibrutinib concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
Measured: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
Percentage of Area Under the Plasma Concentration-Time Curve Obtained by Extrapolation (%AUC[infinity,ex])
The %AUC(infinity,ex) is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100, (AUC[0-infinity] - AUC[0-last])*100/AUC[0-infinity].
Measured: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
Terminal Half-life (t[1/2]) of Ibrutinib
The t(1/2) is defined as 0.693/Lambda (z).
Measured: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
Elimination Rate Constant (Lambda [z]) of Ibrutinib
The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
Measured: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
Adjusted Coefficient of Determination (r^2 [adjusted])
The r^2 [adjusted] for the number of points used in the estimation of lambda[z].
Measured: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
Relative Bioavailability (Frel) of Ibrutinib
The Frel will be calculated as individual Cmax and AUC treatment ratios (for the comparison of food effect). Calculated as: [(AUC[0-infinity][test]/AUC[0-infinity][ref])*(Dose[ref]/Dose[test])]*100.
Measured: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
Metabolite to Parent Ratio for Maximum Plasma Concentration (Cmax) of Ibrutinib
Metabolite to parent drug ratio for maximum observed plasma concentration of Ibrutinib.
Measured: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
Secondary outcomes (1)
Number of Participants with Adverse Events (AEs) and Serious AEs
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Screening up to follow-up (10 plus [+] / minus [-] 2 days after last dose administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390609
- Sponsor's protocol ID
- CR106946
- Other IDs
- 2015-000155-25, PCI-32765CLL1015, 2015
- Status last verified
- Dec 2015
- First submitted
- 11 Mar 2015
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized, Parallel Group, 3- or 4-Way Crossover Bioavailability Study of Ibrutinib Suspension and Sprinkle Formulations Compared to Capsules in Healthy Adults
- ClinicalTrials.gov ID
- NCT02390609
- Acronym / sponsor ID
- CR106946
- Conditions
- Healthy
- Keywords
- Healthy, Ibrutinib, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Mar 2015 (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 relative bioavailability (the extent to which a drug or other substance becomes available to the body) of ibrutinib in healthy adults following single oral dose administration of suspension and sprinkle formulations under fed and fasted conditions compared with capsules under fasted conditions.
Detailed description
This is an open-label (all people know the identity of the intervention), randomized (study medication assigned to participants by chance), 3- or 4-way crossover (participants may receive different interventions sequentially during the trial), and single-center study of ibrutinib. The duration of study will be approximately 67 to 83 days per participant. The study consists of 3 parts: Screening (28 days before study commences on Day 1); Open-label Treatment (consists of 6 treatments, either Ibrutinib capsule or suspension or sprinkle capsule granules under fed or fasted condition), in subsequent 3 periods for Group 1 and 4 periods for Group 2, each separated with washout period of 7 (plus [+] / minus [-] 2) days; and follow up Phase (up to 10 + / - 2 days after last study drug administration). All the eligible participants will be randomly assigned to 1 of the 6 (Group 1) or 4 (Group 2) treatment sequences. In fasted conditions, study drug will be administered following a 10-hour overnight fast. In fed conditions, participants will also fast from food for 10 hours, but will consume a high fat breakfast within a 30-minute period. Study drug will be administered 2 hours after the breakfast. Participants will not be allowed to have food until 4 hours of drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of Ibrutinib will be evaluated primarily. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Group 1: Sequence 1 (ABC) | Experimental | Drug: Ibrutinib (Treatment A) [Reference], Drug: Ibrutinib (Treatment B), Drug: Ibrutinib (Treatment C)Participants will receive Treatment A (Ibrutinib 560 milligram [mg] capsules [reference] under fasted conditions) in Period 1; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 2; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 3. A washout period of 7 (plus [+] / minus [-] 2) days will be maintained between each treatment period. |
| Group 1: Sequence 2 (BCA) | Experimental | Drug: Ibrutinib (Treatment A) [Reference], Drug: Ibrutinib (Treatment B), Drug: Ibrutinib (Treatment C)Participants will receive Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 1; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 2; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period. |
| Group 1: Sequence 3 (CAB) | Experimental | Drug: Ibrutinib (Treatment A) [Reference], Drug: Ibrutinib (Treatment B), Drug: Ibrutinib (Treatment C)Participants will receive Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 1; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 2; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period. |
| Group 1: Sequence 4 (ACB) | Experimental | Drug: Ibrutinib (Treatment A) [Reference], Drug: Ibrutinib (Treatment B), Drug: Ibrutinib (Treatment C)Participants will receive Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 1; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 2; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period. |
| Group 1: Sequence 5 (BAC) | Experimental | Drug: Ibrutinib (Treatment A) [Reference], Drug: Ibrutinib (Treatment B), Drug: Ibrutinib (Treatment C)Participants will receive Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 1; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 2; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period. |
| Group 1: Sequence 6 (CBA) | Experimental | Drug: Ibrutinib (Treatment A) [Reference], Drug: Ibrutinib (Treatment B), Drug: Ibrutinib (Treatment C)Participants will receive Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 1; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 2; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period. |
| Group 2: Sequence 1 (AFDE) | Experimental | Drug: Ibrutinib (Treatment A) [Reference], Drug: Ibrutinib (Treatment D), Drug: Ibrutinib (Treatment E), Drug: Ibrutinib (Treatment F)Participants will receive Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 1; followed by Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 2; followed by Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 3; followed by Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period. |
| Group 2: Sequence 2 (DAEF) | Experimental | Drug: Ibrutinib (Treatment A) [Reference], Drug: Ibrutinib (Treatment D), Drug: Ibrutinib (Treatment E), Drug: Ibrutinib (Treatment F)Participants will receive Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 1; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 2; followed by Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 3; followed by Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period. |
| Group 2: Sequence 3 (EDFA) | Experimental | Drug: Ibrutinib (Treatment A) [Reference], Drug: Ibrutinib (Treatment D), Drug: Ibrutinib (Treatment E), Drug: Ibrutinib (Treatment F)Participants will receive Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 1; followed by Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 2; followed by Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 3; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period. |
| Group 2: Sequence 4 (FEAD) | Experimental | Drug: Ibrutinib (Treatment A) [Reference], Drug: Ibrutinib (Treatment D), Drug: Ibrutinib (Treatment E), Drug: Ibrutinib (Treatment F)Participants will receive Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 1; followed by Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 2; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 3; followed by Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
- If a woman, must not be of childbearing potential: postmenopausal ( greater than [>] 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) >40 International units [IU]/ Liter [L]); surgically sterile
- If a woman, must have a negative serum β-human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test on Day-1 of the each treatment period
- If a man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Body mass index (BMI; weight [kg]/height^2 [m]^2) between 18 and 30 Kilogram (kg)/ meter^2 (m^2) (inclusive), and body weight not less than 50 kg
Key exclusion criteria (5 listed)
- 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, hepatic or renal insufficiency (creatinine clearance below 60 milliliter [mL]/ minute [min]), thyroid disease, neurologic or psychiatric disease, infection, 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, clinical chemistry, 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
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled until completion of the study
- 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 the 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 |
|---|---|---|
| Ibrutinib (Treatment A) [Reference]Participants will receive Ibrutinib 560 milligram (mg) (4*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods. | Drug | Group 1: Sequence 1 (ABC), Group 1: Sequence 2 (BCA), Group 1: Sequence 3 (CAB), Group 1: Sequence 4 (ACB), Group 1: Sequence 5 (BAC), Group 1: Sequence 6 (CBA), Group 2: Sequence 1 (AFDE), Group 2: Sequence 2 (DAEF), Group 2: Sequence 3 (EDFA), Group 2: Sequence 4 (FEAD) |
| Ibrutinib (Treatment B)Participants will receive Ibrutinib 560 mg suspension as Treatment B under fasted conditions in one of the treatment periods. | Drug | Group 1: Sequence 1 (ABC), Group 1: Sequence 2 (BCA), Group 1: Sequence 3 (CAB), Group 1: Sequence 4 (ACB), Group 1: Sequence 5 (BAC), Group 1: Sequence 6 (CBA) |
| Ibrutinib (Treatment C)Participants will receive Ibrutinib 560 mg suspension as Treatment C under fed (high-fat) conditions in one of the treatment periods. | Drug | Group 1: Sequence 1 (ABC), Group 1: Sequence 2 (BCA), Group 1: Sequence 3 (CAB), Group 1: Sequence 4 (ACB), Group 1: Sequence 5 (BAC), Group 1: Sequence 6 (CBA) |
| Ibrutinib (Treatment D)Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment D under fasted conditions in one of the treatment periods. | Drug | Group 2: Sequence 1 (AFDE), Group 2: Sequence 2 (DAEF), Group 2: Sequence 3 (EDFA), Group 2: Sequence 4 (FEAD) |
| Ibrutinib (Treatment E)Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment E under fed (high-fat) conditions in one of the treatment periods. | Drug | Group 2: Sequence 1 (AFDE), Group 2: Sequence 2 (DAEF), Group 2: Sequence 3 (EDFA), Group 2: Sequence 4 (FEAD) |
| Ibrutinib (Treatment F)Participants will receive Ibrutinib 560 mg sprinkle capsule granules suspended in water as Treatment F under fasted conditions in one of the treatment periods. | Drug | Group 2: Sequence 1 (AFDE), Group 2: Sequence 2 (DAEF), Group 2: Sequence 3 (EDFA), Group 2: Sequence 4 (FEAD) |
Primary outcome
Maximum Plasma Concentration (Cmax) of Ibrutinib
Time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
The Cmax is the maximum observed plasma concentration of Ibrutinib.
Time to Reach the Maximum Plasma Concentration (Tmax) of Ibrutinib
Time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
The Tmax is the time to reach the maximum observed plasma concentration of Ibrutinib.
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of Ibrutinib
Time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
The AUC (0-24hrs) is the area under the plasma Ibrutinib concentration-time curve from 0 to 24 hours post dosing.
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (AUC [0-last]) of Ibrutinib
Time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
The AUC (0-last) is the area under the plasma Ibrutinib concentration-time curve from time 0 to time of the last observed quantifiable concentration (C[last]).
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of Ibrutinib
Time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
The AUC (0-infinity) is the area under the plasma Ibrutinib concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma Ibrutinib concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
Percentage of Area Under the Plasma Concentration-Time Curve Obtained by Extrapolation (%AUC[infinity,ex])
Time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
The %AUC(infinity,ex) is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100, (AUC[0-infinity] - AUC[0-last])*100/AUC[0-infinity].
Terminal Half-life (t[1/2]) of Ibrutinib
Time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
The t(1/2) is defined as 0.693/Lambda (z).
Elimination Rate Constant (Lambda [z]) of Ibrutinib
Time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
Adjusted Coefficient of Determination (r^2 [adjusted])
Time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
The r^2 [adjusted] for the number of points used in the estimation of lambda[z].
Relative Bioavailability (Frel) of Ibrutinib
Time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
The Frel will be calculated as individual Cmax and AUC treatment ratios (for the comparison of food effect). Calculated as: [(AUC[0-infinity][test]/AUC[0-infinity][ref])*(Dose[ref]/Dose[test])]*100.
Metabolite to Parent Ratio for Maximum Plasma Concentration (Cmax) of Ibrutinib
Time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
Metabolite to parent drug ratio for maximum observed plasma concentration of Ibrutinib.
1 secondary outcome
Number of Participants with Adverse Events (AEs) and Serious AEs
Time frame: Screening up to follow-up (10 plus [+] / minus [-] 2 days after last dose administration)
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 23 Dec 2015.
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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 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 (Treatment A) [Reference], Ibrutinib (Treatment B) and Ibrutinib (Treatment C) 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 23 Dec 2015. 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?
Maximum Plasma Concentration (Cmax) of Ibrutinib (time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period). The study lists 11 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 23 Dec 2015.